10.14639/0392-100X-N0841
Objective. The COVID-19 pandemic has caused significant impact on healthcare systems worldwide. The rate of infected healthcare workers is &gt; 10% in Italy. Within this dramatic scenario, the development of new personal protective equipment (PPE) devices is mandatory. This study focuses on validation of modified full-face snorkel masks (MFFSM) as safe and protective equipment against SARS-CoV-2 infection during diagnostic and therapeutic procedures on the upper aerodigestive tract.
Methods. Five different MFFSM were tested during otolaryngological surgery and in anaesthesia procedures. Data were collected through an online survey to assess the feedback of operators. pO2 and pCO2 monitoring values during procedures were recorded in selected cases. Results. All five MFFSM tested were easy to use and gave all operators a sound “feeling” of protection. All clinicians involved had common agreement regarding safety and the userfriendly format.
Conclusions. In the future, specific development of different type of masks for protection in the operating room, intensive care units and/or office will be possible as a joint venture between clinicians and developers. Goals for clinicians include better definition of needs and priorities, while developers can devote their expertise to produce devices that meet medical requirements.
application/xml
1827-675X
841
5
en
Giorgio Peretti
https://creativecommons.org/licenses/by-nc-nd/4.0
ACTA Otorhinolaryngologica Italica
anesthesia
Overview of different modified full-face snorkelling masks for intraoperative protection
Text.Serial.Journal
https://www.actaitalica.it/
40
COVID-19
2020-09-24
2020-05-09
2020-12-04
2020-12-09
317-324
1
Giorgio Peretti
2020/09/24
10.14639/0392-100X-N0841
317
IRCCS Ospedale Policlinico San Martino, Unit of Otorhinolaryngology Head and Neck Surgery, Genoa, Italy; Department of Surgical Sciences and Integrated Diagnostics (DISC), University of Genoa, Italy
1827-675X
5
anesthesia
324
Overview of different modified full-face snorkelling masks for intraoperative protection
https://www.actaitalica.it/article/download/841/382
40
ACTA OTORHINOLARYNGOLOGICA ITALICA 2020;40:317-324; doi: 10.14639/0392-100X-N0841




COVID-19


Overview of different modified full-face
snorkelling masks for intraoperative protection
Panoramica delle diverse maschere snorkelling modificate per la protezione
intraoperatoria
Claudio Vicini1, Giovanni Cammaroto1, Giuseppe Meccariello1, Giannicola Iannella1, Marco Fragale2,3,
Tommaso Cacco2,3, Claudio Sampieri2,3, Luca Guastini2,3, Eolo Castello2,3, Giampiero Parrinello2,3, Andrea De Vito4,
Giampiero Gulotta5, Irene Claudia Visconti5, Pietro Abita6, Stefano Pelucchi7, Giulia Bianchi7, Michela Nicole Melegatti7,
Gianluca Garulli8, Filippo Bosco9, Alessandro Gennaiotti9, Stefano Berrettini10, Massimo Magnani11, Marco Troncossi12,
Giorgio Peretti2,3
1
  Department of Head-Neck Surgery, AUSL Romagna, Italy - Ear Nose Throat (ENT) Unit of Forlì and Faenza, University of Ferrara
and Bologna, Morgagni-Pierantoni Hospital, Forlì, Italy; 2 IRCCS Ospedale Policlinico San Martino, Unit of Otorhinolaryngology Head and
Neck Surgery, Genoa, Italy; 3 Department of Surgical Sciences and Integrated Diagnostics (DISC), University of Genoa, Italy; 4 Department
of Head-Neck Surgery AUSL Romagna, Italy - Ear Nose Throat (ENT) Unit, Santa Maria delle Croci Hospital, Ravenna, Italy; 5 Department
of Organ of Sense, University La Sapienza, Rome, Italy; 6 Department of Adult and Development Age Human Pathology “Gaetano
Barresi”, Unit of Otorhinolaryngology, University of Messina, Italy; 7 Otolaryngology Head and Neck Surgery, University Hospital of Ferrara,
Italy; 8 Minimally Invasive General and Thoracic Surgery Unit, AUSL Romagna, Italy - Ceccarini Hospital, Riccione, Italy; 9 Department of
Anesthesia and Intensive Care, Cisanello Hospital, University Hospital of Pisa, Italy; 10 Otolaryngology Head and Neck Surgery, Cisanello
Hospital, University Hospital of Pisa, Italy; 11 Department of Head-Neck Surgery AUSL Romagna, Italy; Ear Nose Throat (ENT) Unit, Bufalini
Hospital, Cesena, Italy; 12 Department of Industrial Engineering, University of Bologna, Italy


SUMMARY
Objective. The COVID-19 pandemic has caused significant impact on healthcare systems                    Received: May 9, 2020
worldwide. The rate of infected healthcare workers is > 10% in Italy. Within this dramatic              Accepted: May 23, 2020
scenario, the development of new personal protective equipment (PPE) devices is manda-                  Published online: September 24, 2020
tory. This study focuses on validation of modified full-face snorkel masks (MFFSM) as safe
and protective equipment against SARS-CoV-2 infection during diagnostic and therapeutic                 Correspondence
procedures on the upper aerodigestive tract.                                                            Claudio Vicini
Methods. Five different MFFSM were tested during otolaryngological surgery and in anaes-                Via Carlo Forlanini 34, 47121 Forlì, Italy
thesia procedures. Data were collected through an online survey to assess the feedback of op-           E-mail: claudio@claudiovicini.com
erators. pO2 and pCO2 monitoring values during procedures were recorded in selected cases.
Results. All five MFFSM tested were easy to use and gave all operators a sound “feeling”                Funding
of protection. All clinicians involved had common agreement regarding safety and the user-              None.
friendly format.
Conclusions. In the future, specific development of different type of masks for protection in the       Conflict of interest
operating room, intensive care units and/or office will be possible as a joint venture between clini-   The Authors declare no conflict of interest.
cians and developers. Goals for clinicians include better definition of needs and priorities, while
developers can devote their expertise to produce devices that meet medical requirements.                  How to cite this article: Vicini C, Cammaroto G,
KEY WORDS: COVID-19, pandemic, surgery, anesthesia                                                        Meccariello G, et al. Overview of different modified
                                                                                                          full-face snorkelling masks for intraoperative pro-
                                                                                                          tection. Acta Otorhinolaryngol Ital 2020;40:317-
RIASSUNTO                                                                                                 324. https://doi.org/10.14639/0392-100X-N0841
Obiettivo. La pandemia di COVID-19 ha tuttora un impatto significativo sui sistemi sanitari di
tutto il mondo. Il tasso di operatori sanitari italiani che hanno contratto l’infezione è superiore     © Società Italiana di Otorinolaringoiatria
al 10%. In questo drammatico scenario, la comunità scientifica si è impegnata nello sviluppo di         e Chirurgia Cervico-Facciale
nuovi dispositivi di protezione individuale. Il nostro studio si concentra sull’uso di maschere da
snorkelling modificate (MFFSM) come dispositivi di protezione individuali contro l’infezione da                        OPEN ACCESS
virus COVID-19 durante procedure diagnostiche e terapeutiche sul tratto aerodigestivo superiore.        This is an open access article distributed in accordance with
Metodi. Cinque diversi tipi di MFFSM sono stati testati. I dati sono stati raccolti attraver-           the CC-BY-NC-ND (Creative Commons Attribution-Non-
so un sondaggio online; solo per la maschera OceanReef Aria QR+ sono stati registrati i                 Commercial-NoDerivatives 4.0 International) license. The
                                                                                                        article can be used by giving appropriate credit and mentio-
valori intraoperatori di pO2 e pCO2.                                                                    ning the license, but only for non-commercial purposes and
Risultati. Tutte le MFFSM testate si sono rivelate di facile utilizzo e tutti gli operatori hanno ri-   only in the original version. For further information: https://
ferito una sensazione di comfort, mantenendo una sensazione di sicurezza durante la procedura.          creativecommons.org/licenses/by-nc-nd/4.0/deed.en




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C. Vicini et al.




Conclusione. In futuro sarà possibile lo sviluppo di specifiche maschere per la protezione in sala operatoria e in terapia intensiva sulla base di
una stretta collaborazione tra clinici e ingegneri. L’obiettivo per i medici sarà definire con precisione le loro esigenze, mentre per le industrie
produttrici sarà mettere a disposizione il loro expertise per fornire dispositivi che incontrino le necessità sanitarie.
PAROLE CHIAVE: COVID-19, pandemia, dispositivi di protezione individuale, maschera, chirurgia, anestesia



Introduction                                                               interface for continuous positive airway pressure (CPAP).
                                                                           After that, diffusion of snorkelling masks as a protective tool
The COVID-19 pandemic has caused significant impact
                                                                           for medical and paramedical staff occurred at a worldwide
on healthcare systems worldwide and is perhaps the most
                                                                           level.
demanding challenge of the last decades. Infected health-
                                                                           The snorkelling mask is a single tool acting, at the same
care workers represent more than 10% of all COVID-19
                                                                           time, as a mouth/nose protection mask and as eye protection
cases in Italy, thus highlighting the relevant involvement
                                                                           glasses. Moreover, the device is waterproof and capable of
of this professional category 1. Unfortunately, there is lim-
                                                                           completely sealing the face of operators. The low price and
ited knowledge about the biological behaviour, transmis-
                                                                           wide availability of these masks make them a potentially rapid
sion and spread of the SARS-CoV-2 virus, and up to now
only empirical treatments and preventive methods against                   and feasible solution to provide PPE during the pandemic.
infection have been employed 2. Direct contact (direct/in-                 Greig et al. 11 were the first authors to publish a case report
direct touching) and virus-containing aerosolised droplets                 on safety testing of a snorkeling mask, which highlighted
during cough, sneezing and speaking within few metres are                  some interesting perspectives.
believed to be the main routes of the spread of infection.                 The standardisation of re-usable devices would lead to a
However, the hypothesis that the virus is diffuse in air, as its           significant reduction of costs and to a reduced need for
predecessor SARS-CoV-1, is well supported 3.                               disposable PPE. However, FDA or CE approval of such
There is evidence that a relevant rate of droplets expired                 equipment is still needed, and research is expected to accelerate.
containing virus become much smaller after water evapora-                  The aim of our multicentre prospective study is to report
tion reaching 5 microns of dimension without gravitation                   on the use of different models of modified full-face snorkel
effects and are free to travel in the air even at considerable             masks (MFFSM) equipped with 3D printed adaptors
distances; experimental studies show that SARS-CoV-2                       for HME and FFP3 filters, evaluating several practical
remains active in aerosols for at least 3 hours and on non-                aspects such as safety and comfort from the perspectives
porous surfaces for up to 72 hours 4-6.                                    of surgeons and anesthesiologists. Taking into account the
These pathways of viral spread and its high stability in in-               demonstrated efficacy of HME and FFP3 filters, our study
door environments can explain the high risk of disease trans-              does not include a specific evaluation of the protective
mission, causing a significant number of nosocomial infec-                 activity of MFFSM against infection. A brief discussion
tions and consequently a high risk of exposure to the virus                of the ethical and regulatory issues, with recommendations
for healthcare personnel. Several other reasons, such as in-               for the future, is also included.
sufficient training of medical and paramedical staff, limited
and partially ineffective diagnostic testing and shortage of               Materials and methods
personal protective equipment (PPE) 7 seem to be the main
causes of the dramatic peaks of infections in hospitals.                   Tests of MFFSM devices were conducted from January-
In particular, shortage of “second level” PPE such as N95,                 April 2020 in three tertiary referral centres: Otolaryngology
FFP-2 and FFP-3 masks has led some authors to investi-                     Unit of the Morgagni-Pierantoni Hospital, Forlì, Italy,
gate the possibility of re-use following feasible sterilisation            Intensive Care Unit (ICU), University of Pisa, Pisa, Italy,
methods 8.                                                                 and Otolaryngology Unit and ICU of IRCCS Ospedale
Swennen et al. 9 proposed a re-usable custom-made 3D-                      Policlinico San Martino, University of Genoa, Genoa, Italy.
printed face mask as a valid alternative in order to reduce                Five different MFFSMs were tested during anaesthesiologic
the need for disposable PPEs.                                              and head-neck surgical procedures in operating room (OR)
Another recently explored solution is the use of 3D printed                and endoscopic evaluations in the ICU. The first and newest
adaptors that support the matching of widely used standard                 versions of Subea Easybreath (Decathlon, Villeneuve-
anesthetic heat and moisture exchange (HME) or industrial                  d’Ascq, France), Seac Unica (Seac Sub, San Colombano
FFP3 filters, to commercially available snorkelling masks 10.              Certenoli, Genova Italy), Siropack C-Voice, (Siropack,
Snorkelling masks were originally introduced in                            Cesenatico, Forlì - Cesena Italy), based on the Unica mask
management of COVID-19 patients as an emergency                            model, and the OceanReef Aria QR+ (Mestel Safety, Genoa,



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Italy) (Figs. 1A-E). Both the first and newest versions of                         system that allows communication between the surgeon
Decathlon masks were modified by the addition of 3D printed                        and/or the anaesthesiologist and the OR and ICU teams
adapters that support the possibility to connect the mask to                       (Fig. 1D).
standard anaesthesiologic filters (HME-FFP2 filter). In the                        The equipment of the surgeon with all different MFFSM
same way, the OceanReef and Unica masks were equipped                              devices is shown in Figure 3. The use of MFFSM during
with a patented adapter coupled to a standard HME filter and                       different surgical procedures is shown in Figure 4. The
industrial FFP3 (Figs. 2A-E).                                                      Seac Unica mask was used only in diagnostic procedures
The Siropack mask has an integrated upper filter and an                            in the ICU such as fibrolaryngoscopies and phoniatric
internal microphone connected to an external amplification                         evaluations.




 A                                         B                                 C                                D                                               E

Figure 1. (A,B) first and newest versions of Decathlon Subea Easybreath mask; (C) Seac Unica mask; (D) Siropack C-Voice mask; (E) Ocean Reef Aria QR+ mask.




 A                                         B                                 C                                D                                               E

Figure 2. (A) 3D printed adapters for Decathlon Subea Easybreath; (B) Decathlon mask connected to standard anaesthesiologic filter (HME-FFP2 filter; arrow)
with a 3D printed adapter; (C) adapter that allows connection of different industrial filters to the Ocean Reef Aria QR+ mask; (D) Seac Unica 3D printed adapter;
(E) industrial FFP3 filters that can be used with the OceanReef Aria QR+ mask.



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C. Vicini et al.




 A                                                     B                                      C                                                        D

Figure 3. Surgeons wearing four different types of modified snorkelling masks; (A) modified Decathlon mask; (B) Siropack C-Voice mask; (C) Ocean Reef Aria
QR+ mask; (D) Seac Unica mask.

                                                                               Information on difficulty in breathing, optical distortion, and
                                                                               perceived weight of each mask was collected in the survey
                                                                               using a Visual Analogue Scale (VAS). These parameters
                                                                               were evaluated with a VAS using a 1-10 numerical rating
                                                                               scale (1 = no impact; 10 = high impact; intermediate values
                                                                               with increasing degrees of impact on tested items). Comfort
                                                                               and fitting, ease of use, and lateral and central vision quality
                                                                               were evaluated with a VAS using a 1-10 numerical rating
                                                                               scale (1 = high impact; 10 = no impact; intermediate values
                                                                               with decreasing degrees of impact on tested items).
                                                                               Communication between members of the surgical team, due
                                                                               to the sound attenuation caused by the mask, was assessed
                                                                               using a VAS with a 1-5 score (1 = poor sound and lower
                                                                               verbal perception 1; 5 = excellent sound and good verbal
                                                                               perception; intermediate values with increasing degrees of
                                                                               impact on tested item). The presence of water condensation
                                                                               that did not allow a clear vision of the surgical field was also
                                                                               investigated and scored as: none, disturbing, not disturbing.
Figure 4. Arrangement of the surgical team, equipped with modified full-
face snorkel masks, during different surgical procedures.                      Finally, localised pressure or facial sores were considered
                                                                               as: none, slight evident, evident with painful.
The subjective analysis for every model of MFFSM was based                     Responses were anonymously collected. Incomplete
on an online survey to assess operators feedback about the                     responses were excluded from the analysis.
mask during different types of anaesthesiologic or surgical                    In addition, with OceanReef mask, PO2 and PCO2 values
procedures in the OR and ICU. The survey was created with                      were objectively monitored during surgical procedures by
Google Survey (Mountain View, California, USA), so that                        positioning a probe on the lobe of the pinna of surgeons
each participant could complete the survey only once.                          (SenTec V - Sign System, SenTec AG, Therwil, Basel,
The survey was developed in an interactive fashion, with                       Switzerland). Cleaning and sterilisation of MFFSM was
drafts revised by four different authors. In the final version                 carried out immediately after each procedure following the
of the survey, there were multiple/single open-ended and                       institutional protocols adopted for goggles and protective
closed-ended questions.                                                        visors, which took about 30 minutes to complete.



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                                                                                                                      Modified full-face snorkel masks for intraoperative protection




Because there is no patient data, this study was exempt                                             Table II. Operator feedback using modified full-face snorkel masks in surgi-
from the need for Institutional Review Board approval.                                              cal procedures.
                                                                                                                                                       Mean         Median
Statistical analysis                                                                                 Ease of wearing                                             9.2 ± 0.8              9
Descriptive statistical analysis was made by Mann-                                                   Comfort and fitting                                         8.6 ± 1.5              9
Whitney U test (SPSS version 22,0; IBM Corp, Armonk,                                                 Central vision quality                                      8.7 ± 1.4              9
NY, USA) to compare different items investigated in three                                            Lateral vision quality                                      6.7 ± 2.1              7
MFFSM devices. Since it was not used for anaesthesiologic                                            Optical distortion of the surgical field                    2.8 ± 2.1              2
and surgical procedures, data for the Seac Unica mask was                                            Difficulty in breathing                                     2.7 ± 2.3              2
excluded from statistical analysis.                                                                  Perceived weight of the mask                                3.8 ± 2.7              2
                                                                                                     Communication with team during surgery*                      3.7 ±1                4
Results                                                                                              Surgeon pCO2 min**                                         32.7 ± 0.5
                                                                                                     Surgeon pCO2 max**                                         37.1 ± 0.5
General results
All procedures were performed in COVID-19 free                                                       Surgeon p02 mean**                                         96.8 ± 0.8
patients, confirmed by preoperative polymerase chain                                                 Localised pressure or facial sores
                                                                                                     Not evident                                                     48               96%
reaction (PCR) test on nasal and oro-pharyngeal swabs.                                               Slight evident                                                   2                4%
Modified Decathlon masks (with COVIDIEN® DAR                                                         Evident with painful                                             -                 -
HME filter) were tested in 25 surgical and anaesthesiologic                                         * all items except “time of surgery” were scored with a numerical rating scales of VAS = 0-10;
procedures in the OR, Siropack in 15, and Ocean Reef in                                             “communication with team during surgery” was scored with a numerical rating scale of VAS =
                                                                                                    0-5; ** values measured by operators who have tested the Ocean Reef mask; *** Seac Unica
10, respectively; Seac Unica was used in only 56 diagnostic                                         mask was excluded from statistical analysis because it was not used in surgical procedures.

Table IA. Type of modified full-face snorkelling masks and number of proce-                         endoscopic evaluations in the ICU. The mean duration of
dures performed in OR and ICU.
                                                                                                    surgical and anaesthesiologic procedures was 55.9 minutes
 Number of all procedures                                     N = 106
                                                                                                    (Tab. IA). Data about surgical procedures are shown in
 Modified Decathlon masks (HME filter)                                         25 (24%)
 Siropack mask (HME filter)                                                    15 (14%)
                                                                                                    Table IB.
 Ocean Reef Aria (P3 industrial filter)                                         10 (9%)             Operator feedback about the MFFSM during surgical
 Seac Unica (HME filter)                                                       56 (53%)             procedures was presented in Table II and plotted in
                                                                                                    Figure 5. Ease of wearing, comfort and fitting, achieved a
Table IB. Number and type of surgical and anesthesiologic procedures in OR.                         median score of 9.
 Number of surgical and anesthesiologic procedures            N = 50                                Central vision quality showed a median value of 9, whereas
 ENT surgery                                                                   35 (70%)             the median score for lateral vision was 7. Despite the mean
 Anaesthesiologic procedures                                                   15 (30%)
                                                                                                    excellent outcomes, both Decathlon masks, especially the
 Role of surgeon/operator                                                                           first model, caused optical distortion at the converging gaze
 Intubation                                                                    15 (30%)
 First surgeon                                                                 19 (38%)             and was given a low score.
 Second surgeon                                                                 7 (14%)             The absence of condensation inside the mask was reported
 Third surgeon                                                                 9 (18%)              by 94% of operators. On the other hand, the presence of
 Type of anaesthesia                                                                                condensation drops inside the chin valve was reported by
 General anesthesia                                                            48 (96%)
 Local anaesthesia                                                              2 (4%)
                                                                                                    some operators using Decathlon masks, especially after
                                                                                                    prolonged use (> 40 minutes), but did not interfere with the
 Type of procedures
 Tracheotomy                                                                   19 (38%)             procedures. Ninety-six percent of testers did not complain
 Oro-tracheal intubation                                                       15 (30%)             of localised pressure or facial sores after use of the mask.
 Hemi-thyroidectomy                                                             5 (10%)
 Parotidectomy                                                                 5 (10%)
 Total thyroidectomy                                                            4 (8%)              Operator feedback by mask
 Neck dissection                                                                1 (2%)              Differences in parameters between all masks used in
 Transoral robotic surgery                                                      1 (2%)              surgical settings are reported in Table IIIA.
 Mean time of surgical procedures (min)*                                         55.9               The quality of communication with the teams through
 Standard deviation                                                              45.5               the mask showed a significant difference in terms of
 Higher value                                                                     180
 Lower value                                                                        5               effectiveness between the Siropack vs Decathlon masks
 Median                                                                            40               (p = 0.04). By contrast, the Siropack model was felt to
*Seac mask was excluded from statistical analysis because it was not used in surgical procedures.   have a greater perceived weight compared to the others



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C. Vicini et al.




Figure 5. Box plot; operator feedback on the use of modified full-face snorkelling masks (Seac Unica excluded).

Table IIIA. Operator feedback: differences between modified Decathlon, Siropack, and Ocean Reef masks.
                                                 Modified Decathlon mask             Siropack mask                                        Ocean Reef mask                          p
 Time of surgery                                                        48.0 ± 55.8                           55 ± 36.3                       53.5 ± 18.7                      > 0.05
 Ease of wearing                                                          9.4 ± 1                             8.9 ± 0.7                        9.5 ± 0.5                       > 0.05
 Comfort and fitting                                                     8.7 ± 1.8                            8.1 ± 0.7                        9.1 ± 0.7                       > 0.05
 Central vision quality                                                  8.8 ± 1.7                            8.3 ± 2.2                         9 ± 0.8                        > 0.05
 Lateral vision quality                                                   7± 2.8                               6.5 ± 1                         6.8 ± 0.7                       > 0.05
 Optical distortion of the surgical field                                2.9± 2.7                             2.4 ± 1.1                        3.1 ± 2.2                       > 0.05
 Difficulty in breathing                                                 2.9 ± 2.9                            2.7 ± 2.3                        2.1 ± 2.4                       > 0.05
 Perceived weight of the mask                                            2.9 ± 2.4                            5.8 ± 1.1                        1.8 ± 0.5                       0.03 *
 Communication with team during surgery****                               3 ± 0.9                             4.1 ± 0.7                        3.8 ± 0.7                       0.04 **
                                                                                                                                                                               0.3 ***
* Siropack vs decathlon and Ocean Reef mask; ** Siropack vs decathlon; *** Siropack vs Ocean Reef mask; **** all items except “time of surgery” were scored with a numerical rating scales of VAS
= 0-10; “communication with team during surgery” was scored with a numerical rating scale of VAS = 0-5; Table IIIB; Operator feedback using modified Seac Unica in ICU procedures.

(p = 0.03) due to the integration of a microphone and                                              Central vision quality with the Seac Unica mask showed
external amplificatory system (Tab. IIIA).                                                         a mean value of 9.1, lateral vision quality of 9 and optical
On the other hand, concerning the remaining items, no                                              distortion of 8 (Tab. IIIB).
significant differences were seen between Siropack and
                                                                                                   Table IIIB. Operator feedback using modified Seac Unica in ICU procedures.
OceanReef masks.
                                                                                                                                        Average value            Median
During pO2/pCO2 monitoring with the Ocean Reef model,
                                                                                                    Ease of wearing                                    8.2 ± 2.3                       9
the mean value of pO2 was 96.8 mmHg and the mean of the
                                                                                                    Comfort and fitting                                9.1 ± 1.4                       9
highest pCO2 values recorded was 37.1 mm H2O, which
                                                                                                    Central vision quality                             9.1 ± 1.2                       9
was within the normal range (p < 40 mm H2O).
                                                                                                    Lateral vision quality                             9.0 ± 1.6                       9
Notably, ICU operators performed more than one procedure
                                                                                                    Optical distortion                                 2.0 ± 2.0                       1
without removing the mask. Each procedure took a mean
                                                                                                    Difficulty in breathing                            2.6 ± 2.0                       2
time of 25 minutes, while the mean total wearing time
                                                                                                    Perceived weight of the mask                       3.5 ± 2.4                       3
was 4 hours. Condensation was reported only by operators
                                                                                                    Communication with team                             4.2 ±1                         4
wearing the mask for more than 4 hours, which did not,                                             * all items were scored with a numerical rating scales of VAS = 0-10; “communication
however, interfere with the procedures.                                                            with team” was scored with a numerical rating scale of VAS = 0-5.




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                                                                                  Modified full-face snorkel masks for intraoperative protection




Discussion                                                           circulation in the mask. However, due to the similar structure
                                                                     of all devices analysed, this objective parameter is likely to be
The COVID-19 pandemic, worldwide, was characterised in its           similar to the other masks as well.
first phase by a shortage of PPE, especially high-performance        However, comparison between MFFSMs and other
filtering masks FFP2 and FFP3 for healthcare workers (HCW).          conventional protective devices must be carefully taken into
For this reason, industrial PPE devices (mask, filters, goggles)     account. FFP2-3 masks, for instance, loose their filtering
are tested and commonly employed for COVID-19 patients in            efficacy if they wet due to fluid penetration in the fabric;
hospitals and more generally in healthcare systems.                  therefore, in case of incomplete face sealing, viral inhalation
It is also extremely important to underline that all                 could not be excluded. Moreover, the need for FFP2-3 masks
HCW performing trans-nasal and trans-oral endoscopic                 to be disposable increases both costs and problems related to
examinations (i.e. pharyngo-laryngoscopy, bronchoscopy,              their disposal.
etc.) are exposed to the highest risk of infection6. Therefore, an   Surgical goggles usually limit the vision inferiorly and laterally,
adequate prevention of risk should be adopted, starting from         often become foggy and cause significant discomfort. Face
the assumption that all patients are potentially infected with       shields can be cumbersome, without adequate ventilation.
SARS-CoV-2 until proven otherwise.                                   On the basis of our experience, the utilisation of a single
For these reasons, the scientific community has punctually           full-face protection device such as a MFFSM instead of a
reported detailed international protocols and recommendations        combination of a FFP2 mask and goggles seems to be more
to minimise the risk of viral diffusion and infection, including     user-friendly. Moreover, the respiratory fit test of the MFFSMs
the observance of specific surgical and anaesthesiologic             seems to be much more reliable than the respirator fit test of a
procedures, new surgical team settings and constant use of           conventional FFP2 mask.
adequate PPE 12,13.                                                  The wide range of responses for items related to the comfort
In this dramatic scenario, the development of new PPE                may reflect the less well-defined concept of “comfort” and
devices is mandatory to guarantee all HCW the safest level of        individual sensitivity to a claustrophobic feeling induced by
protection and comfort. Our study focused on the validation          prolonged use of the device, but no significant differences
of MFFSMs as safe and protective equipment against SARS-             were seen among the different models.
CoV-2 infection, testing and both judging subjectively               The optical properties of the masks may play a key role in their
and objectively the efficacy and usability of these personal         effective use in a surgical setting. Central vision was described
and customised devices during diagnostic and therapeutic             as sufficient by most operators, but the masks were rated as
procedures on the upper aerodigestive tract.                         critical in terms of lateral view, which is much less important
All tests were performed in patients who were confirmed to           during intubation manoeuvers. Different amounts of optical
be SARS-CoV-2 negative. The aim of the study was to test             distortion were described for all the MFFSMs, such as barrel,
the feasibility of the masks before using them on COVID-19           pincushion, and mustache, which is related to the different
positive cases.                                                      shapes of the transparent shield of the masks. However, the
All the masks tested are currently available on the market,          optical distortion value was rated as non-critical for all masks.
and significant differences in the quality among the devices         Some breathing difficulty was reported by operators using all
were not seen.                                                       types of MFFSM, which is probably related to the strength
All MFFSMs tested were easy to use and gave all operators a          of air flow of the respiratory system which is plugged by a
sound “feeling” of protection. It is also worth mentioning that      filtering membrane. The moderate increase in dyspnoea was
the average score of the item related to the ease of wearing         mainly related to individual sensitivity and use of a double
showed a median value of 9.                                          filter vs a single filter.
The actual viral filtration capability was not tested and was not    Furthermore, all MFFSM originally designed for snorkelling
the goal of the present study. However, the filtering power of       did not allow the use of loupes or even normal glasses. In light
the system is based on the anaesthesiologic and professional         of this, an integrated magnification system and lighting would
filters, which are certified and widely used for a long time. The    be useful, especially for specialists facing with diseases of the
immediate possibility to combine commercial snorkelling masks        upper airways. This issue could be overcome by customised
with dedicated filters renders MFFSMs a safety emergency tool        development of a new mask that is specific for clinical and
than can be successfully and immediately employed.                   surgical needs.
The values of pCO2 were tested only for the OceanReef                Another critical issue of extreme importance to be considered
mask, which were always within normal ranges throughout              in future is to decrease, as much as possible, the weight of the
the procedure, objectively showing the stability of respiratory      device, even with the integration of different accessories, to
parameters that indicate correct breathing and normal air            avoid discomfort and neck fatigue.



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All MFFSM evaluated are immediately available and may be            Zanchini a group of very talented and enthusiastic dreamers.
considered to be a practical emergency solution for personal        A special mention for Siropack owners Rocco De Lucia e
protection in the operating room and ICU for Head and               Barbara Burioli. They provided for free most of the masks
Neck and Anaesthesiologist teams during the COVID-19                included in the study. A special thanks to Eng. Gamberini,
pandemic. MFFSMs could play a key role in the emergency             manager of the Ocean Reef Company, a leader for individual
when conventional PPE (FPP2 or FPP3, transparent shields            protection systems and to Dr. Princi, Project manager for their
or goggles) is not immediately available or are in shortage.        support for this project. We would like to express our sincere
All the teams included in the study considered MFFMs to be          gratitude to Mr. Arata Daniele, President of Seac-Group for
a valid and interesting alternative option, even in the case that   supporting our research, providing us novel and valuable
conventional PPE is available.                                      insights for clinical practice. We are also grateful to Istituto
All models provided a waterproof barrier for the eyes, nose and     Italiano di Tecnologia (IIT) staff in the figures of engineer
mouth, which means for the entire face. The internal sealed         Michele Gesino (Senior Technician) and engineer PhD Luca
respiratory space is filtered by certified devices, giving the      Fiorio (Chief Technician).
user a reasonable level of biological safety, awaiting official
certification. Breathing in the mask seems to be perceived in       References
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