Operating Room Setup: How to Improve Health Care Professionals Safety During Pandemic COVID-19

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.

Introduction

SARS-CoV-2, causing the disease COVID-19, has expanded from China and is being exported to the world becoming pandemic. In Italy, 25,071 health care professionals (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 during surgery. There is still no definitive data on COVID-19 characteristics, mode of transmission, diagnostic criteria, and 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 generated favoring the transmission of the virus. Therefore, correct observance of procedures and protocols aimed primarily at the safety of patients and health personnel will be essential. Operative room (OR) setting needs to be carefully 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 suggest the best devices reducing the HCP risk of contamination. This study has been performed in line with the Standards for 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 intervention 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 surgical goggles (covered sides of eyes) or face shield, surgical shoes should be fluid resistant and easily to be decontaminated, disposable socks should not be worn due to the higher risk of undressing contamination. According to the International 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 requirements 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 properties; 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 μm. 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) filters. Common standards require that a HEPA filter must remove at least 99.95% or 99.97% of particles whose diameter is equal to 0.3 μm. HEPA are the filters of choice for infection control airborne precautions (“Understanding respiratory protection options in healthcare: the overlooked elastomeric”. 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 μm) or N95 (N95 masks filter at least 95% of particles <0.3 μm in diameter) masks should be used in combination with level 3 ASTM (American Society of Testing and Materials American 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 respiratory 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 region. 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 surgical 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 procedure. 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 completed before patient's arrival.

The patient's documentation should be placed in the OR to minimize the contamination to one room. All OR doors 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 transmission 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

(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

(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 fundamental.

(b) Have alternative and ready-to-use plans.

(d) Preparation of both vasopressor and anesthesia inducing 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 attempt. 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 operator to the left of the first. Preoxygenation without ventilation is recommended for 3–5 minutes with the mask as 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 action 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, immediately 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 nasogastric 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 patient 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.

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.

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 minute). 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.

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, pulmonary 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 temperatures >100°C. Vaporized tissue plume consists of 95% water vapor and 5% combustion byproducts and is considered potentially hazardous (various chemicals, particles, virulent viruses, and bacteria). (Munro MG. Fundamentals of electrosurgery Part I: principles of radiofrequency energy for surgery. The Society of American Gastrointestinal and Endoscopic 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 and bipolar electrosurgery generate a higher temperature than ultrasonic or radiofrequency instruments. Radiofrequency ablation and ultrasonic scalpels have a similar mechanism of action and are operated at a similar temperature of 50°C–100°C. 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 mandatory 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 μm) with electrosurgical unit smoke evacuation system and another surgical aspirator (HERCULES^®, whisperator, general aspirator; 0.7366+ m Hg, 0.19 m³ per minute) should offer sufficient aspiration performance against virus' spread. The CooperSurgical Smoke Evacuation System 6080A-50 three-stage air filtration system and CONMED's ClearView™ are used to remove airborne 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 ventilation 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, desufflation 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 μ ULPA filter. PneumoClear and AirSeal reduce the leak of gas during instrument exchange and improve laparoscopy quality reducing the camera fogging. However, the CO₂ recirculation using AirSeal could concentrate the aerosolized viruses.

PneumoClear can desufflate the abdomen at the end of the surgery.

Direct suction to laparoscopic trocars could allow an accurate 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

OR must have a HEPA filter.

Negative pressure OR must have a high air exchange cycle rate (≥25 cycles/h).

Every supply kit should be packed and placed in the OR before patient arrival.

Checklist of equipment and devices in the operating room should be always performed and completed before patient arrival.

We recommend the use of AAMI-Level-III surgical gowns.

We recommend wearing double latex-free gloves with AQL lower than 1.0 (Sempermed^® syntegra uv surgical gloves).

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 recommended due to the higher risk for HCP.

Rapid sequence intubation is strongly recommended.

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 combination with surgical aspirator in open surgery. (CONMED's ClearView™)

11.

We recommend low pneumoperitoneum pressures, Stryker PneumoClear or Conmed iFS AirSeal to reduce the leak of gas during instrument exchange and desufflate the abdomen using a smoke evacuation device in combination with Medtronic-DARTM Filter HMEs.

Footnotes

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.

References

Guimarães

, Timerman

, Rodrigues

RDR

, et al. Position statement: Cardiopulmonary resuscitation of patients with confirmed or suspected COVID-19 -2020. Posicionamento para Ressuscitação Cardiopulmonar de Pacientes com Diagnóstico ou Suspeita de COVID-19—2020. Arq Bras Cardiol, 2020; 114:1078–1087.

Coccolini

, Perrone

, Chiarugi

, Di Marzo

, Ansaloni

, Scandroglio

, Marini

, Zago

, De Paolis

, Forfori

, Agresta

, Puzziello

, D'Ugo

, Bignami

, Bellini

, Vitali

, Petrini

, Pifferi

, Corradi

, Tarasconi

, Pattonieri

, Bonati

, Tritapepe

, Agnoletti

, Corbella

, Sartelli

, Catena

. Surgery in COVID-19 patients: Operational directives. World J Emerg Surg, 2020; 15:25.

Luo

, Cao

, Wei

, et al. Precautions for intubating patients with COVID-19. Anesthesiology, 2020; 132:1616–1618.

Cook

, El-Boghdadly

, McGuire

, McNarry

, Patel

, Higgs

. Consensus guidelines for managing the airway in patients with COVID-19: Guidelines from the Difficult Airway Society, the Association of Anaesthetists the Intensive Care Society, the Faculty of Intensive Care Medicine and the Royal College of Anaesthetists. Anaesthesia, 2020; 75:785–799.

Peng

PWH

, Ho

, Hota

. Outbreak of a new coronavirus: What anaesthetists should know. Br J Anaesth, 2020; 124:497-501.

Huang

, Zeng

, Xie

, Huang

, Wei

, Pan

. How to perform tracheal intubation for COVID-19 patients safely and effectively: Experience AND tips from Sichuan, China. J Clin Anesth, 2020; 64:109800.

Duggan

, Mastoras

, Bryson

. Tracheal intubation in patients with COVID-19. CMAJ, 2020; 192:E607.

Soar

, Lott

, Böttiger

, et al. Erweiterte lebensrettende Maßnahmen bei Erwachsenen: COVID-19-Leitlinien des European Resuscitation Council [Advanced life support in adults European Resuscitation Council COVID-19 Guidelines]. Notf Rett Med, 2020; 23:248–250.

Manson

, Damrose

. Does exposure to laser plume place the surgeon at high risk for acquiring clinical human papillomavirus infection?. Laryngoscope, 2013; 123:1319–1320.

10.

Jones

, Munro

, Feldman

, et al. Fundamental use of surgical energy (FUSE): An essential educational program for operating room safety. Perm J, 2017; 21:16–050.

11.

, Park

, Sohn

, et al. Experimental study of the potential hazards of surgical smoke from powered instruments. Br J Surg, 2015; 102:1581–1586.

12.

Benson

, Maskrey

, Nembhard

, Unice

, Shirley

, Panko

. Evaluation of personal exposure to surgical smoke generated from electrocautery instruments: A pilot study. Ann Work Expo Health, 2019; 63:990–1003.

13.

Kwak

, Kim

, Seo

, Song

. Detecting hepatitis B virus in surgical smoke emitted during laparoscopic surgery. Occup Environ Med, 2016; 73:857–863.

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