Aerosol Box Use During Cardiopulmonary Resuscitation for Cardiac Arrest and Coronavirus Protection

Recruiting at 3 trial locations

Overseen By Adam Cheng, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: KidSIM Simulation Program

Disqualifiers: Physical limitations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

240 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Aerosol box for coronavirus protection during cardiopulmonary resuscitation?

The use of aerosol boxes has been studied for their potential to limit aerosol dispersion, which is important for protecting healthcare workers from airborne diseases like COVID-19 during procedures that generate aerosols, such as cardiopulmonary resuscitation. However, studies have shown that while they may offer some protection, they can also increase the time needed for procedures like intubation, potentially putting patients at risk. ^{1 2 3 4 5}

Is the aerosol box safe for use during medical procedures?

The aerosol box, used to protect against virus spread during procedures like intubation, may increase the time needed for these procedures and could lead to risks like low oxygen levels in patients. It might also damage protective gear, potentially putting healthcare workers at risk of infection. More research is needed to confirm its safety. ^{1 2 4 6 7}

How does the aerosol box treatment differ from other treatments for cardiac arrest and coronavirus protection?

The aerosol box is a unique treatment used during cardiopulmonary resuscitation to limit the spread of aerosols, which can contain viruses like COVID-19. Unlike traditional personal protective equipment, the aerosol box acts as a physical barrier to protect healthcare workers from infection, although it may increase the time needed for procedures like intubation. ^{1 2 4 5 7}

Research Team

Adam C Cheng, MD

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for healthcare workers who perform CPR and other airway management procedures, such as doctors, nurses, respiratory therapists, and physician assistants. They must be certified in Advanced Life Support or Basic Life Support. Those unable to consent or with physical limitations that prevent task performance are excluded.

Inclusion Criteria

Airway Provider: Attending physician, fellow or resident in adult or pediatric emergency medicine, pediatric intensive care, general pediatrics or pediatric/adult anesthesia

I am a healthcare professional certified to perform CPR.

I am certified in Basic Life Support or Advanced Life Support.

Exclusion Criteria

I cannot do certain tasks because of my physical limitations.

Decline to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Orientation

Participants view orientation videos and practice intubation and CPR with or without the aerosol box

1 day

1 visit (in-person)

Simulation

Teams participate in two sequential simulation scenarios to evaluate the impact of aerosol box use

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the simulation

4 weeks

Treatment Details

Interventions

• Aerosol box

Trial Overview The study tests the effectiveness of an aerosol box designed to protect healthcare workers from airborne particles during CPR on patients with COVID-19. It aims to understand particle dispersion during these procedures and improve infection control measures.

Participant Groups

Group I: Aerosol Box Experimental Treatment 1 Intervention

The team will complete the resuscitation scenario with an Aerosol box placed.

Group II: No Aerosol Box Active Control 1 Intervention

The team will complete the resuscitation scenario without an Aerosol box placed.

Who Is Running the Clinical Trial?

KidSIM Simulation Program

Lead Sponsor

Trials

10

Recruited

2,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of an Aerosol Box on Intubation in Simulated Emergency Department Airways: A Randomized Crossover Study. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Simulation and evaluation of the protective barrier enclosure for cardiopulmonary resuscitation. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A quantitative evaluation of aerosol generation during cardiopulmonary resuscitation. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The aerosol box for intubation in coronavirus disease 2019 patients: an in-situ simulation crossover study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Aerosol boxes for airway management in coronavirus disease patients: a clinical retrospective study in Mexico. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Barrier Techniques to Reduce Aerosolization During Cardiopulmonary Resuscitation. [2020]

7. India pubmed.ncbi.nlm.nih.gov

Intubation outcomes using the aerosol box during the COVID-19 pandemic: A prospective, observational study. [2022]