Impact of Aerosol Box Use During Cardiopulmonary Arrest: A Multicenter Study
1 other identifier
interventional
240
2 countries
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 Coronavirus Disease 2019 (COVID-19) pandemic was 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, endotracheal Intubation (ETI) and chest compressions are sometimes required 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 procedures, 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, more specifically during the provision of cardiopulmonary resuscitation (CPR). 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 explore how an aerosol box performs in reducing contamination of HCW's who perform critical airway interventions during resuscitation events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedSeptember 5, 2025
August 1, 2025
2 years
May 11, 2023
August 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of overall excellent CPR
A continuous measure defined as percentage of chest compressions (CC) meeting American Heart Association guidelines for CC depth and rate at the same time during resuscitation
Immediately after simulated resuscitation
Secondary Outcomes (9)
Time to successful intubation
Immediately after simulated resuscitation
CC fraction
immediately after simulated resuscitation
Time to initiation of CPR
Immediately after simulated resuscitation
Disease particle concentration (ppm) at head of bed and over patient torso
Measured at 2, 4, 6, 8, and 10 minutes of simulated resuscitation.
Provider workload
Immediately after simulated resuscitation
- +4 more secondary outcomes
Study Arms (2)
Aerosol Box
EXPERIMENTALThe team will complete the resuscitation scenario with an Aerosol box placed.
No Aerosol Box
NO INTERVENTIONThe team will complete the resuscitation scenario without an Aerosol box placed.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Airway Provider:
- Attending physician, fellow or resident in adult or pediatric emergency medicine, pediatric intensive care, general pediatrics or pediatric/adult anesthesia
- Adult or Pediatric Advanced Life Support certification.
- CPR Provider:
- Attending physician, resident, fellow, nurse, respiratory therapist, physician assistant or health care aide
- Basic Life Support, 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Department of Emergency Medicine, Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
KidSIM, Alberta Children's Hospital
Calgary, Alberta, T3B6A8, Canada
Department of Pediatrics, The Hospital for Sick Children
Toronto, Ontario, Canada
Department of Pediatrics, CHU Sainte-Justine
Montreal, Quebec, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam C Cheng, MD
University of Calgary
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Departments of Pediatrics and Emergency Medicine
Study Record Dates
First Submitted
May 11, 2023
First Posted
May 22, 2023
Study Start
September 1, 2023
Primary Completion
September 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
September 5, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share