Evaluation of Foreign Body Airway Obstruction Interventions Through Simulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Odds Ratio of Airway Obstruction Relief Within One-Minute
研究概览
简要总结
WHY IS THIS STUDY BEING DONE? Little is known about the best treatment for choking. New airway clearance devices like LifeVac© and Dechoker© are being sold to help a choking person. Researchers do not know how well they work compared to other techniques like abdominal thrusts or back blows.
The purpose of this research study is to see how well bystanders can use the choking techniques.
RESEARCH QUESTION Among laypersons, which FBAO intervention (abdominal thrusts, LifeVac©, or Dechoker©) results in the greatest proportion of FBAO relief within one-minute?
PARTICIPANTS Adults aged 18 years or greater.
INTERVENTIONS View a video of each choking intervention, and then complete a choking scenario where participants will try to relieve an airway obstruction on a simulation mannequin. The three interventions are: LifeVac, Dechoker, and Abdominal Thrusts. Participants will be invited back between 90-120 days to repeat the scenarios to assess retention.
详细描述
Foreign body airway obstructions (FBAO, choking) result in significant mortality and morbidity globally . If left untreated, individuals suffering from airway obstructions will progress to unresponsiveness and die. For the first time in decades, a novel choking intervention is being promoted. Airway clearance devices (such as LifeVac© or Dechoker©) are non-powered suction-based devices being marketed by manufacturers as a safer, easier alternative to traditional choking interventions. However, a systematic review, conducted by Dunne et al, demonstrated insufficient evidence to recommend their use in choking guidelines. Subsequently, a mannequin simulation trial by Patterson found LifeVac© to be superior to abdominal thrusts at FBAO relief within 4 minutes (odds ratio [OR] 47.32 [95%CI 5.74 - 389.40]), whereas Dechoker© was not (OR 1.22 [95% CI 0.60 - 2.47]). This study was only conducted in healthcare professionals, and the efficacy in laypersons is still unknown.
Study Objectives 1. To evaluate the relative efficacy of airway clearance devices compared to traditional interventions among laypersons.
Research Questions and Hypotheses
- Among laypersons, which FBAO intervention (abdominal thrusts, LifeVac©, or Dechoker©) results in the greatest proportion of FBAO relief within one-minutes?
Hypothesis: LifeVac© will relieve more FBAOs within one-minute compared to abdominal thrusts and Dechoker© based on a prior mannequin study among healthcare professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
Nil, however, Outcomes Assessor will be blinded to study hypothesis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All adult laypersons (Aged 18 years or older)
- •Able to communicate in English (to sign informed consent)
排除标准
- •Physical disability limiting the performance/use of the interventions
- •Individuals with healthcare training (e.g., physicians, nurses, paramedics, respiratory therapists or associated students)
结局指标
主要结局
Odds Ratio of Airway Obstruction Relief Within One-Minute
时间窗: 1 minute
This outcome will be calculated using a mixed-effect logistic regression model, after assessment for group, carryover and period effect. Time will be calculated from when the participant first touches the mannequin to the time that the simulated food bolus is expelled from the mannequin's mouth. Comparison will be made between different pairs of devices.
次要结局
- Hazard Ratio of Time to Airway Obstruction Relief (Retention Testing)(Maximal time allotted is 4 minutes)
- Odds Ratio of Airway Obstruction Relief Within Four-Minutes(4 minutes)
- Hazard Ratio of Time to Airway Obstruction Relief(Maximal time allotted is 4 minutes)
- Odds Ratio of Airway Obstruction Relief Within Four-Minutes (Retention Testing)(4 minutes)
- Odds Ratio of Airway Obstruction Relief Within One-Minute (Retention Testing)(1 minute)