Impact of Aerosol Box Use on Healthcare Provider Contamination

NCT04880668 | Completed

• 1 other identifier: REB20-0893
• Study Type: interventional
• Target: 122
• Locations: 2 countries
• Sites: 4

Brief Summary

Aerosol Generating Medical Procedures (AGMP) are procedures that have the potential to create tiny particles suspended in the air. These particles can contain germs such as viruses. The current Coronavirus Disease 2019 (COVID-19) pandemic is caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Patients infected with SARS-CoV-2 experience unusually high rates of critical illness that needs advanced airway management and intensive care unit admission. Bag-valve-mask (BVM) ventilation, laryngeal mask airway insertion (LMA), and endotracheal Intubation (ETI) are common AGMP for critically ill COVID-19 patients, and may contribute to a high risk of infection amongst Health Care Workers (HCW). To lessen HCW risk during high-risk AGMPs, a device called an aerosol box has been developed to place over the head of the patient, shielding the provider's face from virus droplets suspended in the air. The purpose of this research study is to better understand how particles disperse during AGMPs. The project team hopes what is learned from the project can help inform infection control measures. This could help make changes to the clinical environment and make it safer for HCW's. The investigators intend to investigate how an aerosol box performs in reducing contamination of HCW's who perform critical airway interventions.

Conditions

Coronavirus; Covid19; COVID-19 Acute Respiratory Distress Syndrome

Keywords

simulation; AGMP; aerosol generating medical procedure; intubation; bag valve mask ventilation; laryngeal mask airway

Outcome Measures

Primary Outcomes (2)

• Change in Integrated Density (Pre vs Post Doffing)

  Integrated density of HCP contamination, quantified from digital photos of GloGerm™ deposited on the airway team members pre and post-doffing.

  Immediately after each procedure (BVM, ETI, LMA)

• Change in Area of contamination (Pre vs Post Doffing)

  Quantified from digital photos of GloGerm™ deposited on the airway team members pre and post-doffing.

  Immediately after each procedure (BVM, ETI, LMA)

Secondary Outcomes (8)

• Time to task completion

  Immediately after ETI and LMA procedures

• First pass success rate

  Immediately after ETI and LMA procedures

• Number of healthcare providers contaminated

  Immediately after each procedure (BVM, ETI, LMA)

• Number of different body parts contaminated

  Immediately after each procedure (BVM, ETI, LMA)

• Environmental Contamination

  Immediately after each procedure (BVM, ETI, LMA)

Study Arms (2)

Control - No aerosol box

NO INTERVENTION

Participants will perform the AGMP without an aerosol box

Intervention - Aerosol box

EXPERIMENTAL

Participants will perform the AGMP with an aerosol box

Device: Aerosol Box (Splashguard)

Interventions

Aerosol Box (Splashguard) DEVICE

The aerosol box is a transparent, plastic cube covering the patient's head and shoulders, with circular access ports on the front of the box allowing for access to manage the airway. An additional four access holes (i.e. two on either side of the box) allow for airway assistants to access the patient airway.

Intervention - Aerosol box

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All genders eligible
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthcare provider from inpatient unit, intensive care unit, operating room unit and/or emergency department
• Attending physician or fellow in emergency medicine, intensive care, pediatrics, or anesthesia
• Adult or Pediatric Advanced Life Support certification
• Healthcare provider from inpatient unit, intensive care unit, operating room unit and/or emergency department
• Attending physician, resident, fellow, nurse or respiratory therapist
• Adult or Pediatric Advanced Life Support certification.

You may not qualify if:

• Decline to provide informed consent
• Unable to perform tasks required of the role due to physical limitations.

Sponsors & Collaborators

• KidSIM Simulation Program: lead
• International Network for Simulation-based Pediatric Innovation, Research and Education: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

Department of Emergency Medicine, Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

KidSIM-ASPIRE Simulation Research Program Alberta Children's Hospital

Calgary, Alberta, Canada

Location

Department of Pediatrics, The Hospital for Sick Children

Toronto, Ontario, Canada

Location

Department of Pediatrics, CHU Sainte-Justine

Montreal, Quebec, Canada

Location

Related Publications (1)

• Cheng A, Pirie J, Lin Y, Lo CY, Davidson J, Chang T, Matava C, Buyck M, Harel DS, Collia N, Neveu G, Pellerin S, Madadi M, Manshadi K, Wan B, Levy A; International Network for Simulation-based Pediatric Innovation, Research and Education (INSPIRE) Aerosol-Generating Medical Procedure (AGMP) Investigators. Aerosol Box Use in Reducing Health Care Worker Contamination During Airway Procedures (AIRWAY Study): A Simulation-Based Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e237894. doi: 10.1001/jamanetworkopen.2023.7894.

  PMID: 37043197 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Adam Cheng, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Unable to blind due to the nature of the intervention
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial, two study arms

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 11, 2021
• Study Start: June 11, 2021
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (3)