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.

Impact of Aerosol Box Use During Cardiopulmonary Arrest: A Multicenter Study

Cardiac Arrest

COVID-19

Coronavirus

Problem to be addressed. The overwhelming scale and severity of the Coronavirus Disease 2019
      (COVID-19) pandemic has presented a serious threat to the health of frontline health care
      workers (HCWs). Aerosol-generating medical procedures (AGMPs), such as bag-valve-mask (BVM)
      ventilation, endotracheal intubation (ETI), and cardiopulmonary resuscitation (CPR) are
      commonly required for critically ill COVID-19 patients. AGMPs produce airborne particles,
      contributing to the disproportionately high risk of infection amongst HCWs working in acute
      care areas. Strategies to mitigate HCWs exposure to and infection from COVID-19 are required
      to maintain the integrity of the healthcare workforce. To minimize HCW exposure during AGMPs,
      aerosol box devices have been developed to provide a physical barrier between the patient and
      the HCW, with the intent of shielding HCWs from disease particles.

      The aerosol box, and its various different adaptations, have been implemented by hospitals
      around the world for managing critically ill patients with COVID-19. Studies to date have
      demonstrated that aerosol box use potentially reduces spread of aerosolized particles, but
      its use is also associated with technical challenges. Studies to date have focused primarily
      on the task of ETI, without any evidence describing the impact of aerosol box use on chest
      compressions (CC). Furthermore, most studies suffer from small sample sizes, provided minimal
      (or no) training on aerosol box use, recruited individuals (and not resuscitation teams) as
      participants, failed to quantify the degree of contamination on providers, or failed to
      measure airborne particle counts. The study team recently completed a multicenter randomized
      trial comparing aerosol box vs. no box use and demonstrated delayed time to intubation with
      aerosol box use. However, the study was done in a limited context (short procedure, airway
      team of 2 providers, CC not measured), thus making generalizability to team-based
      resuscitative care questionable. To date, there have been no single or multicenter studies
      concurrently evaluating the effect of aerosol box use on CPR quality, airborne particle
      concentration, and HCW contamination during team-based resuscitative care. As a consequence,
      it is still unknown if aerosol boxes are effective in protecting HCWs, and if aerosol box use
      negatively impacts care during cardiopulmonary arrest.

      The importance and relevance of simulation-based aerosolization studies is highly dependent
      upon the use of a realistic model for aerosolization. Several groups have reported
      aerosolization devices in the form of cough simulation devices ranging from hand-held
      syringes, nasal atomizers, spray guns, bag-valve masking and more advanced air flow-based
      devices to simulate cough. Unfortunately, none of these cough simulators were designed for
      user-controlled settings of respiratory mechanics (eg. respiratory rate, volume, flow) while
      also allowing for performance of intubation and chest compressions. This study represents the
      first aerosol box study to use an aerosolization device comprised of a respiratory simulator
      allowing for control of respiratory mechanics that closely mimic those of a real patient,
      while concurrently allowing performance of AGMPs.

      Our study will provide evidence to: (a) evaluate if use of an aerosol box adversely affects
      time to completion and quality of critical resuscitation tasks; and (b) determine if aerosol
      boxes are effective in reducing airborne particle counts and provider contamination during
      team-based cardiac arrest resuscitation. Our long-term goal is to provide empiric evidence to
      enhance HCW safety while delivering high quality care during cardiopulmonary resuscitation.
      This will be accomplished by creating a cardiac arrest scenario within a controlled simulated
      clinical environment, as conducting a similar study on real patients would be fraught with
      challenges and risks.

      Why is a trial needed now? New COVID-19 variants, variable uptake of immunizations, and
      waning immunity amongst the immunized population contribute to the persistent threat of the
      COVID-19 pandemic. We've learned how quickly the pandemic can change course, and how it is
      important to plan for future pandemics caused by different viruses. Now, more than ever, it
      is critical to identify strategies to protect healthcare workers from infection. HCW
      infection has led to workforce shortages that negatively impact patient outcome. Aerosol
      boxes have been used in some parts of the world to protect HCWs during the pandemic, but
      existing evidence gaps have prevented its widespread adoption. A better understanding of
      particle dispersion patterns, HCW contamination patterns, and impact on clinical task
      performance during resuscitative care will help to inform international cardiac arrest
      guidelines.

      How will the results of this trial be used? Research assessing strategies to mitigate HCW
      risks of contamination are critical to maintaining a viable healthcare workforce during the
      pandemic. The proposed study provides further evidence informing the potential use of aerosol
      boxes during simulated cardiopulmonary arrest. The research will be the first to provide a
      quantitative measure of airborne particles and HCW contamination patterns in conjunction with
      clinically important outcome measures. In combination, these metrics provide key information
      that will inform clinical practice, institutional airway management and cardiac arrest
      policies. Through partnerships (e.g. Heart and Stroke Foundation of Canada) and longitudinal
      engagement of key local and national public health agency stakeholders, the results of this
      study will be shared with policymakers to enable evidence-based adaptations to clinical
      protocols. Existing partnerships within the International Network for Simulation-based
      Pediatric Innovation, Research and Education (INSPIRE network) will enable rapid
      dissemination of aerosol box training material across all continents if results are positive.
      As an author on international COVID-19 and cardiac arrest resuscitation guidelines, the PI
      will engage stakeholders to ensure results inform future International Liaison Committee on
      Resuscitation (ILCOR) guidelines for or against use of the aerosol box.

      Trial design. A prospective, randomized controlled trial will be conducted across five sites
      in North America. Simulation-based research confers the advantage of answering research
      questions without risk of harm to HCWs or patients. Three participants will be recruited to
      play the roles of airway provider, and two CPR providers in the management of a simulated,
      critically ill COVID-19 patient. CPR providers will be trained to provide CPR coaching to
      each other. Two trained research assistants will participate in the resuscitation team as a
      team leader and bedside nurse/airway assistant and perform these roles in a standardized
      manner. Team leaders will not provide any guidance or coaching on CPR quality. Participants
      will be randomized by team into either the control arm (i.e. no aerosol box) or the
      intervention arm (i.e. use of aerosol box) (Figure 1). Following randomization, all
      participants will view a short video orienting them to the simulated clinical environment.
      Intervention arm teams will view an additional 5-minute video orienting them to the design of
      the aerosol box and including expert-modeled demonstration of strategies for optimal airway
      management and delivery of CPR. This includes how to move the patient within the aerosol box
      to optimize delivery of CPR. The training video will be filmed in English and French to
      permit viewing across all study sites. After viewing the video, participants will work in
      teams to practice intubation and CPR (with aerosol box in place) for a maximum of 15 minutes,
      providing them opportunity to coordinate their movements to optimize efficiency. After each
      procedure, they will receive feedback from a local airway and aerosol box expert (i.e. site
      investigator). Control arm teams will also have opportunity to practice intubation and/or CPR
      for 15 min (without aerosol box). After orientation and training, teams will participate in
      two sequential simulation scenarios. The order of scenario delivery will be randomized to
      eliminate scenario order as a potential confounder. At the end of the entire session,
      participants will receive an educational debriefing to discuss performance issues, infection
      control measures, and technical skills using a blended-method approach to debriefing. The
      Investigators elected not to use a cross-over study design because of insufficient washout
      time (between scenarios) and the potential carry-over effects of learning from the prior
      scenario influencing performance in the subsequent scenario.

Aerosol box

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

Professor, Departments of Pediatrics and Emergency Medicine

The time required by the team to successfully pass the endotracheal tube after patient becomes apneic.

The percentage of time performing CC during cardiac arrest.

The time required for the team to initiate CPR after the patient becomes pulseless

Measurement of the concentration of simulated disease particles in the air at certain positions at defined time points.

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

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

Assessed using the the State-Trait Anxiety Inventory (STAI)

Captured by questionnaire completed by both participants (multiple choice and open field question types) on their perceptions about using the box.

Areas will be quantified from digital photos of GloGerm™ 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.

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

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

Impact of Aerosol Box Use During Cardiopulmonary Arrest: A Multicenter Study

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status