JOURNAL OF LAPAROENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES

Volume 31, Number 1, 2021 Technical Reports

ª Mary Ann Liebert, Inc.
DOI: 10.1089/lap.2020.0592

Operating Room Setup:

How to Improve Health Care Professionals Safety During
Pandemic COVID-19—A Quality Improvement Study

Gennaro Perrone, MD,1 Mario Giuffrida, MD,2 Valentina Bellini, MD,3

Alessandro Lo Coco, RN,4 Vittoria Pattonieri, MD,1 Elena Bonati, MD,2 Paolo Del Rio, MD, PhD,2
Elena Giovanna Bignami, MD, PhD,3 and Fausto Catena, MD, PhD1
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Abstract

Background: COVID-19 is a terrific pandemic and a potential risk for every health care professional (HCP),
especially during emergency conditions where the right timing is essential for the correct treatment. During
surgery the correct setting of operative room (OR) is mandatory to reduce the risk of contamination. Personal
protection equipment (PPE), specific devices, and planned OR setting are essential during surgery in pandemic
COVID-19.
Methods: Medline, PubMed, Scientific societies recommendations, and guidelines were consulted to identify
articles reporting the setup of OR during pandemic COVID-19.
Results: OR must have a high-efficiency particulate air (HEPA) filter with negative pressure and a high air
exchange cycle rate. Every supply kit should be packed and placed in the OR before patient arrival. A detailed
checklist of equipment and devices is necessary. Personal PPE at the highest level should be provided to every
HCP (Association of the Advancement of Medical Instrumentation [AAMI]-Level-III surgical gowns; double
latex-free gloves with Acceptable Quality Level <1.0; FFP3 or powered air-purifying respirator masks with face
shield). Anesthesia should be performed with a rapid sequence intubation. During surgery energy devices
should be settled to the lower level in combination with a smoke evacuation switch pen with disposable smoke
evacuation HEPA filter to minimize surgical smoke spread. During laparoscopy low pneumoperitoneum
pressures and aspiration systems must be provided.
Conclusions: Emergency surgery during pandemic COVID-19 increases the risk for every HCP in the OR.
A theoretical risk of transmission from the surgical field exists. It is mandatory the adoption of strong strategies
to reduce the risk of contamination in the OR.

Keywords: COVID-19, operating room safety, health care professionals, surgery

Introduction during surgery. There is still no definitive data on COVID-19

characteristics, mode of transmission, diagnostic criteria, and

S ARS-CoV-2, causing the disease COVID-19, has ex-

panded from China and is being exported to the world
becoming pandemic. In Italy, 25,071 health care profes-
sionals (HCP) were contaminated at May 12, 2020 (https://
www.epicentro.iss.it).
Contamination of HCP during surgery has been known for
many years and is well described. Several viruses have been
implicated to different degrees in the contamination of HCP
management protocols. The known transmission route is the
air route, therefore attributable to droplets and aerosols.
During urgency or emergency surgery and especially during
anesthesiologic procedures, aerosols and fumes can be gen-
erated favoring the transmission of the virus. Therefore,
correct observance of procedures and protocols aimed pri-
marily at the safety of patients and health personnel will be
essential. Operative room (OR) setting needs to be carefully

1
Department of Emergency Surgery, Parma University Hospital, Parma, Italy.
2
General Surgery Unit, Department of Medicine and Surgery, Parma University Hospital, Parma, Italy.
3
Anesthesiology, Critical Care and Pain Medicine Division, Department of Medicine and Surgery, University of Parma, Parma, Italy.
4
Department of Surgery, Parma University Hospital, Parma, Italy.

85
 86
evaluated and improved to prevent the infection of HCP,
especially in emergency/urgency surgery. Infection control
strategies during pandemic COVID-19 in OR has been
evaluated and several scientific associations have provided
different guidelines on management of OR during COVID-
19. Higher levels of protection, infection control systems, and
how they should be implemented in different phases of the
surgical process are mandatory during pandemic COVID-19.
The aim of this study is to give a precious advice to HCP
during surgery in emergency/urgency.
Methods
Medline, PubMed, Scientific societies recommendations,
and guidelines were consulted to identify articles reporting
the setup of OR during pandemic COVID-19. Data sheet of
every personal protection equipment (PPE), surgical and
anesthesiologic devices were analyzed, and compared to sug-
gest the best devices reducing the HCP risk of contamination.
This study has been performed in line with the Standards for
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Quality Improvement Reporting Excellence (SQUIRE) criteria.
General Considerations
It is important for every HCP to evaluate and understand
every possible operating room scenario.
All staff must be specifically trained and dispose of PPE.
HCP should enter in the OR in a timely manner to minimize
exposure to infected patients. The number of HCP involved
in surgery should be minimized. HCP involved in the inter-
vention should not leave the OR during the procedure.
Handwashing is essential. Every HCP should clean the hands
by using alcohol-based hand rub or soap and water before
starting every procedure (https://www.who.int), wear surgi-
cal goggles (covered sides of eyes) or face shield, surgical
shoes should be fluid resistant and easily to be decontami-
nated, disposable socks should not be worn due to the higher
risk of undressing contamination. According to the Interna-
tional Safety Equipment Association (ISEA) and U.S.
Federal Emergency Management Agency (FEPA) (https://
safetyequipment.org/) (https://beta.sam.gov/) the goggles
and face shield under consideration must meet the require-
ments of ANSI/ISEA Z87.1-2010. Goggles must be indirectly
vented, include solid side shields and include antifog lenses.
Face shield must cover the front and sides of the face; be full
face length with outer edges of the face shield reaching at least
to the point of the ear; include chin and forehead protectors;
cover the forehead; include a single Velcro strap and or elastic
strap; treated for antiglare, antistatic, and antifogging proper-
ties; equivalent or similar to Medline NONFS300.
The HCP should wear clean scrub and disposables cap and
mask. Mask should be chosen carefully considering surgical
procedure and the aerosol-generating risk level. FFP3 masks
protect from poisonous and deleterious kinds of dust, smoke,
and aerosol. The total leakage may amount to a maximum of
5% and they must filter 99% of all particles measuring up to
0.6 lm. A powered air-purifying respirator (PAPR) should be
used in ENT and thoracic surgery. 3M-PAPR consists of
a half or full facepiece, breathing tube, battery-operated
blower, and high-efficiency particulate air (HEPA only) fil-
ters. Common standards require that a HEPA filter must re-
move at least 99.95% or 99.97% of particles whose diameter
is equal to 0.3 lm. HEPA are the filters of choice for infection
GENNARO ET AL.
control airborne precautions (‘‘Understanding respiratory
protection options in healthcare: the overlooked elastomer-
ic’’. NIOSH Science Blog. Retrieved April 21, 2020).1
When FFP3 and PAPR masks are not available the FFP2
(FFP2 masks filter at least 94% of particles <0.6 lm) or N95
(N95 masks filter at least 95% of particles <0.3 lm in di-
ameter) masks should be used in combination with level 3
ASTM (American Society of Testing and Materials Ameri-
can Society of Testing and Materials) surgical mask. Surgical
masks alone are not recommended. Surgical masks do not
provide the wearer with a reliable level of protection from
inhaling smaller airborne particles and is not considered re-
spiratory protection. (https://www.cdc.gov/)
OR Setting
Every OR should have a HEPA filter. OR should have a
separate atmospheric air inlet and outlet exhaust system. OR
should have a negative pressure to minimize infection risk
with a high air exchange cycle rate (‡25 cycles/h) to reduce
the viral load within OR.2
All OR doors should be well sealed once the patient is
transferred in and no one should exit from OR during the
procedure. Latex-free material should be always used in the
emergency OR setting. Entering in the OR every HCP should
wear the first latex-free surgical gloves, then a long-sleeved
water-resistant gown and second latex-free gloves. The inner
pair of gloves: covering the skin (‘‘like a second skin’’) and
the outer pair of gloves: gloves on top of gloves (‘‘working
gloves’’). Surgical gowns are rated by Association of the
Advancement of Medical Instrumentation (AAMI) based on
the level of fluid protection in the critical zone or chest re-
gion. AAMI-Level-III surgical gowns are recommended.
According to US ANSI/AAMI PB70 surgical gowns that
claim moderate to high barrier protection of Level 3 and
Level 4 must be used. A second surgical gown should be
mandatory, especially for surgeons and instrumentalist nurse
during greater dispersion of fluids surgery.
Surgical gloves must have the low as possible pinhole rate
according to the European standards and directive 89/686/
EEC or US ANSI/AAMI PB70. Surgical gloves during
pandemic COVID-19 should have an ‘‘Acceptable Quality
Level’’ (AQL) <1.0. We suggest Sempermed syntegra uv
surgical gloves. They are synthetic polyisoprene latex-free
gloves with an AQL value of 0.65. Latex-free surgical gloves
must meet ASTM D5250-19 standard specifications (for
polyvinylchloride) or ASTM D6977 standard specifications
(for polychloroprene). (https://beta.sam.gov/)
Every material and instruments necessary during all sur-
gical procedures, from anesthesia to patient’s transfer outside
the OR, should be packed into dedicated kit. All required
surgical material for every surgical procedure (vascular,
thoracic, general surgery, and urology) should be packed in a
sterilizable steel wire basket. Every supply kit should be
placed in the OR before patient arrival to prevent unnecessary
HCP circulation outside the OR during the surgical proce-
dure. The scout nurse and the surgeon should provide the kit
necessary for surgery. Checklist of equipment and devices in
the operating room should be always performed and com-
pleted before patient’s arrival.
The patient’s documentation should be placed in the OR to
minimize the contamination to one room. All OR doors
 HOW TO IMPROVE HCP SAFETY DURING COVID-19
should be well sealed once the patient is transferred in and no
one should exit from OR during the procedure. Once the
patient has been discharged by the OR, HCP, including
environmental services personnel, should exit from the
OR individually with special attention to avoid self-
contamination during PPE doffing.
Anesthesia
A correct and scrupulous management of the airways will
also be fundamental as it is the closest route to the trans-
mission of the virus.
Evaluate the correct anesthesiologic management in the
preoperative phase. General anesthesia should be reduced,
where possible, favoring locoregional anesthesia techniques
to avoid the dispersion of the virus by managing the airways.
(http://www.siaarti.it)
Preparation for anesthesia and airway management
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(1) Be ready to welcome the patient in the room with the
least number of operators.
(a) a FIRST expert operator
(b) a second expert ASSISTANT operator
(c) a third expert nurse operator
(d) a fourth operator who observes outside the room in
which the airways will be managed ready to request
help.3,4
(2) (a) Perform a correct checklist of the aids necessary
for rapid airway management with more familiar
techniques. Make sure that the closed-circuit fan is
working properly.
Basic devices:
- Guedel cannulas
- Direct laryngoscope with Macintosh blade
- Macintosh blade video laryngoscope
- Second-generation supraglottic aids
- Endotracheal tubes (7–8 internal diameter for women,
8–9 for men) with fixings and lubrication of the same
- ‘‘va e vieni’’, AMBU ball, face masks
- Aspiration.
The presence and use of HEPA filters will be funda-
mental.
(b) Have alternative and ready-to-use plans.
(c) Predict difficult intubations using the EGRI score
(‡4) or MACOCHA score.
(d) Preparation of both vasopressor and anesthesia in-
ducing drugs.
(3) Monitor the patient to have a complete picture of his
vital parameters (PA, FC, FR, SAT%, BIS).4,5
Induction anesthesia airway management
The management of the airway in an emergency or in
nonemergency contexts must be as simple and quick as
possible, with the aim of obtaining the result at the first at-
tempt. It would be better if there was a fixed team for the
intubation of suspected or confirmed COVID-19 patients.6
The first operator is located at the head of the patient, the
second operator to the right of the first and the third op-
erator to the left of the first. Preoxygenation without ven-
tilation is recommended for 3–5 minutes with the mask as
87
tight as possible. Oxygenation with nasal cannulas is not
recommended. The reverse Trendelenburg position is
important.
Rapid sequence intubation is strongly recommended:
(1) Rapid Drug Administration:
0.1 mg/kg MIDAZOLAM 1–2 mcg/kg FENTANYL
1–2 mg/kg PROPOFOL
1.2 mg/kg ROCURONIUM
Alternatively, it is recommended:
1–2 mg/kg KETAMINE
1.2 mg/kg ROCURONIUM
Rocuronium as a neuromuscular blocker whose rapid ac-
tion allows rapid intubation and during which the patient is
not ventilated.
(2) Intubation:
Intubation with VIDEOLARYNGOSCOPE is strongly
recommended to reduce the physical distance between the
operator and the patient and to reduce the dispersion of
droplets. Once the intubation has been performed, immedi-
ately cuff the same and prepare to fix it, it will be useful to
clamp the endotracheal tube before connecting the tube to the
closed circuit.
(3) Check:
Difficult to auscultate the chest therefore essential will be
the confirmation given by etCO2 and the clinic based on the
expansion of the chest.
Complete the procedure with the placement of a naso-
gastric probe.7
Only if extremely necessary and with difficulty after three
intubation attempts, declare the INTUBATION FAILURE
and follow the DAS 2018 guidelines.
Plan B: positioning of second-generation supraglottic
protection and/or ventilation with two-hand facial mask.
Plan C: declare bankruptcy of plan b and prepare for a
FONA.4
Tracheal extubation and noninvasive ventilation
Patient extubation must be performed at the end of all
surgical procedures and in the presence of the least number of
operators, if the clinical and hemodynamic conditions of
patient allow it.
(1) Make sure that the devices are ready for use.
(2) Aspirate secretions into the oral cavity.
(3) Administer drugs to reduce cough and vomiting
episodes.
(4) Use SUGAMMADEX 2–4 mg/kf as a Rocuronium
antagonist is recommended.
(5) Immediately after extubation, make sure that the pa-
tient is wearing a face mask with oxygen supply,
making it adhere well to the face of the patient
(preferably with two hands).
(6) Monitor the patient and replace the surgical mask on
the patient’s face.
7) Once these procedures are completed, ensure that the
patient returns to the ward through established routes.4
Intraoperative cardiac arrest management
Stop surgical procedures or hurry to finish them.
 88
Initiate resuscitation maneuvers according to the ACLS
protocol as indicated by the AHA guidelines and by the ERC-
IRC guidelines for cardiopulmonary resuscitation during the
COVID-19 pandemic.
Check the airway (A–B).
If no circulation (C):
(1) Ask for HELP.
(2) Start cardiopulmonary resuscitation (CPR) early with
chest compressions (100–120 compressions per min-
ute). The maneuver can be performed by the surgeon.
(3) Connect electrodes:
 If in a SHOCKABLE rhythm (TV/FV) temporarily
interrupt CPR and deliver SHOCK every 2 minutes
(first shock 200 J—second shock 300 J—third shock
360 J).
Administer ADRENALINE 1 mg every 2–5 minutes.
Administer AMIODARONE alternating with adrenaline
for two doses: first dose 300 mg—second dose 150 mg.
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 If in rhythm NOT SHOCKABLE (PEA/ASYSTOLE):
Administer ADRENALINE 1 mg every 2–5 minutes NOT
by stopping the CPR.
Research 5H/5T (hypovolemia, hypoxia, hydrogen ions,
hypoglycemia, hypothermia; buffering, pneumothorax, pul-
monary thromboembolism, coronary thrombosis, toxic/
trauma).7,8
In children:
- DEFIBRILLATION >1 year (first SHOCK 2 J/kg,
second and subsequent 4 J/kg)
- ADRENALINE 0.01 mg/Kg
- AMIODARONE 5 mg/kg (Duff et al. RN, MSN, FAHA
e AHA Guidelines Focused Updates Highlights Project
Team).
Surgery
Several studies have evaluated the transmission of viruses
through surgical smoke during surgical treatment, especially for
HPV transmission. There are no evidences that the aerosolized
virus’ RNA or DNA could be transmitted to the surgeon.9
Data about coronavirus’ spread during surgery are not
reported but surgical approach in the emergency setting
during pandemic COVID-19 should be carefully evaluated to
prevent HCP contamination. Open surgery determines a
smoke exposure during several types of electrocautery-based
procedures. Surgical smoke is released when energy-
generating medical instruments raise intracellular tempera-
tures >100C. Vaporized tissue plume consists of 95% water
vapor and 5% combustion byproducts and is considered po-
tentially hazardous (various chemicals, particles, virulent
viruses, and bacteria). (Munro MG. Fundamentals of elec-
trosurgery Part I: principles of radiofrequency energy for
surgery. The Society of American Gastrointestinal and En-
doscopic Surgeon (SAGES) Manual on the Fundamental Use
of Surgical Energy.10
Surgical smoke plume ranges from <0.01 microns to >200
microns with a majority between 0.3 and 0.5.
Surgical smoke varies greatly in its nature depending on
the energy device that creates it. Monopolar electrosurgery
GENNARO ET AL.
and bipolar electrosurgery generate a higher temperature than
ultrasonic or radiofrequency instruments. Radiofrequency ab-
lation and ultrasonic scalpels have a similar mechanism of
action and are operated at a similar temperature of 50C–
100C. Radiofrequency ablation does not generate viable cells
in the surgical smoke. Ultrasonic scalpel generates cooler
aerosols. Low-temperature vaporization have a greater chance
of carrying infectious and viable materials than the higher-
temperature aerosols. Electrocautery power should be reduced
to low thermal spread as possible to decrease the diffusion of
the overall potential inhalation exposure to surgical smoke
plume components.11 Vaporized tissue plume should be always
collected by an appropriate mechanical evacuation system.
The use of smoke evacuation systems and PPE is manda-
tory in the emergency surgical setting.
During open surgery an adapted aspiration system should
be used. A disposable filter should be fitted to eliminate
smoke from the surgical site. Generally, smoke evacuation
systems are not powerful enough to evacuate large quantities
of smoke. A capture device integrated into the handpiece of
electrosurgical equipment (Stryker-Neptune SafeAir Smoke
Evacuation Pencil) (Pencavac-Smoke Evacuation Switch
Pen smoke with disposable Smoke Evacuation HEPA Filter
kit; bacterial filtration efficiency >99.99% virus filtration
efficiency >99.99%) (ULPA-Ultra Low Penetration Air
filters with a retention coefficient of at least 99.999% for
particles of at least 0.1 lm) with electrosurgical unit smoke
evacuation system and another surgical aspirator (HER-
CULES, whisperator, general aspirator; 0.7366+ m Hg,
0.19 m3 per minute) should offer sufficient aspiration per-
formance against virus’ spread. The CooperSurgical Smoke
Evacuation System 6080A-50 three-stage air filtration sys-
tem and CONMED’s ClearView are used to remove air-
borne particulate plume. ULPA filtration provides efficiency
level for 0.014 microns rated at 99.999% (Environmental
Protection Agency EPA-CICA Fact Sheet, EPA-425/F-03-
023. Title: Air Pollution Control Technology Fact Sheet 2013).
Benson et al. have demonstrated that the increased venti-
lation rate in the OR resulted in a more rapid decrease in
measured particle concentrations.12
Several studies on viral emission during laparoscopy have
demonstrated the spread of viruses through surgical smoke.13
The SAGES during pandemic COVID-19 has suggested
the use of filters for the released CO2 during laparoscopy and
robotic surgery. The main problems with laparoscopy are the
one-way valves trocars in which there are the risks of gas
leak during instruments exchange and the desufflation of
pneumoperitoneum.
Opening the trocar stopcocks allows the spread of the
laparoscopic gas diffusely into the OR. Using a low set
pressure during laparoscopic procedures reduces the volume
of aerosolized particles. At the end of the operation, desuf-
flation should be carefully performed through a direct suction
or a smoke evacuator device. Stryker PneumoClear and
Conmed iFS AirSeal (ASM-EVAC) facilitate smoke
evacuation and filtration with 0.01 l ULPA filter. Pneumo-
Clear and AirSeal reduce the leak of gas during instrument
exchange and improve laparoscopy quality reducing the
camera fogging. However, the CO2 recirculation using Air-
Seal could concentrate the aerosolized viruses.
PneumoClear can desufflate the abdomen at the end of
the surgery.
 HOW TO IMPROVE HCP SAFETY DURING COVID-19
Direct suction to laparoscopic trocars could allow an ac-
curate evacuation of the smoke. Direct suction using
Medtronic-DAR Filter HMEs, a breathing system filter,
could aspire >99.999% of viruses.
Conclusion
Emergency surgery during pandemic COVID-19 increases
the risk for every HCP in the OR.
A theoretical risk of transmission from the surgical field
exists. These recommendations during surgery may mitigate
any possible risks of transmission of COVID-19.
It is mandatory the adoption of strong strategies to reduce
the risk of contamination in the OR.
Recommendations
1. OR must have a HEPA filter.
2. Negative pressure OR must have a high air exchange
cycle rate (‡25 cycles/h).
3. Every supply kit should be packed and placed in the
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OR before patient arrival.
4. Checklist of equipment and devices in the operating
room should be always performed and completed
before patient arrival.
5. We recommend the use of AAMI-Level-III surgical
gowns.
6. We recommend wearing double latex-free gloves
with AQL lower than 1.0 (Sempermed syntegra uv
surgical gloves).
7. We recommend FFP3 or PAPR mask with Medline
NONFS300 face shield. If FFP3 or PAPR mask are
not available, the FFP2 or N95 plus surgical musk
must be used. Surgical mask alone is not re-
commended due to the higher risk for HCP.
8. Rapid sequence intubation is strongly recommended.
9. We recommend lower energy settings to minimize
surgical smoke when energy devices are needed.
10. We recommend smoke evacuation switch pen with
disposable smoke evacuation HEPA filter in combi-
nation with surgical aspirator in open surgery.
(CONMED’s ClearView)
11. We recommend low pneumoperitoneum pressures,
Stryker PneumoClear or Conmed iFS AirSeal to re-
duce the leak of gas during instrument exchange and
desufflate the abdomen using a smoke evacuation
device in combination with Medtronic-DARTM Fil-
ter HMEs.
Disclosure Statement
No competing financial interests exist.
Funding Information
The authors received no financial support for the research,
authorship, and/or publication of this article.
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Address correspondence to:
Mario Giuffrida, MD
General Surgery Unit
Parma University Hospital
Via A. Gramsci 14
Parma 43126
Italy
E-mail: mario.giuffrida4@gmail.com
 This article has been cited by:

1. Jeffrey Braithwaite. 2021. Quality of care in the COVID-19 era: a global perspective. IJQHC Communications 1:1. . [Crossref]
2. Massimiliano Cernigliaro, Davide Negroni, Miriana Sassone, Andrea Paladini, Alessandro Carriero, Luca Saba, Giuseppe Guzzardi.
2021. Observational study on healthcare workers protection in the angiographic suite during the SARS-CoV-2 pandemic: before
and during vax era. Journal of Public Health Research . [Crossref]
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