跳至主要内容
临床试验/NCT05868239
NCT05868239招募中不适用

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

KidSIM Simulation Program6 个研究点 分布在 2 个国家目标入组 240 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240
试验地点
6
主要终点
Percentage of overall excellent CPR

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Percentage of overall excellent CPR

时间窗: Immediately after simulated resuscitation

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

次要结局

  • Time to initiation of CPR(Immediately after simulated resuscitation)
  • Pros and cons of using aerosol box(Immediately after simulated resuscitation)
  • Time to successful intubation(Immediately after simulated resuscitation)
  • CC fraction(immediately after simulated resuscitation)
  • Area of HCP contamination (cm2) for CPR providers(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)
  • Quality of intubation performance(Immediately after simulated resuscitation)
  • Provider Anxiety(Immediately after simulated resuscitation)

研究者

发起方
KidSIM Simulation Program
申办方类型
Network
责任方
Principal Investigator
主要研究者

Adam Cheng

Professor, Departments of Pediatrics and Emergency Medicine

University of Calgary

研究点 (6)

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