COVID-19 Clinical Trial
Official title:
Impact of Aerosol Box Use During Cardiopulmonary Arrest: A Multicenter Study
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.
Status | Not yet recruiting |
Enrollment | 240 |
Est. completion date | December 1, 2026 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: 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 Exclusion Criteria: - Decline to provide informed consent - Unable to perform tasks required of the role due to physical limitations. |
Country | Name | City | State |
---|---|---|---|
Canada | KidSIM, Alberta Children's Hospital | Calgary | Alberta |
Canada | Department of Pediatrics, CHU Sainte-Justine | Montreal | Quebec |
Canada | Department of Pediatrics, The Hospital for Sick Children | Toronto | Ontario |
United States | Department of Emergency Medicine, Children's Hospital of Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
KidSIM Simulation Program | Canadian Institutes of Health Research (CIHR) |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Time to successful intubation | The time required by the team to successfully pass the endotracheal tube after patient becomes apneic. | Immediately after simulated resuscitation | |
Secondary | CC fraction | The percentage of time performing CC during cardiac arrest. | immediately after simulated resuscitation | |
Secondary | Time to initiation of CPR | The time required for the team to initiate CPR after the patient becomes pulseless | Immediately after simulated resuscitation | |
Secondary | Disease particle concentration (ppm) at head of bed and over patient torso | Measurement of the concentration of simulated disease particles in the air at certain positions at defined time points. | Measured at 2, 4, 6, 8, and 10 minutes of simulated resuscitation. | |
Secondary | Provider workload | Provider workload as measured by NASA (National Aeronautics and Space Administration) TLX (Task Load Index) survey, rated on a scale of 0-20, with 20 being maximum workload for each element | Immediately after simulated resuscitation | |
Secondary | Quality of intubation performance | Assessed using a previously published intubation checklist - data captured by video review of both video laryngoscopy and video from within the room. Rated on a scale of 0 to 41, with 41 being perfect performance | Immediately after simulated resuscitation | |
Secondary | Provider Anxiety | Assessed using the the State-Trait Anxiety Inventory (STAI) | Immediately after simulated resuscitation | |
Secondary | Pros and cons of using aerosol box | Captured by questionnaire completed by both participants (multiple choice and open field question types) on their perceptions about using the box. | Immediately after simulated resuscitation | |
Secondary | Area of HCP contamination (cm2) for CPR providers | Areas will be quantified from digital photos of GloGermâ„¢ deposited on CPR providers pre and post-doffing. A digital reference grid will be applied over each photo, with surface area within each grid "pixel" calculated using Image J (NIH) software. | Immediately after simulated resuscitation |
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