Evaluation of Foreign Body Airway Obstruction Interventions Through Simulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Calgary
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Odds Ratio of Airway Obstruction Relief Within One-Minute
Study Overview
Brief Summary
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.
Detailed Description
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
1. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Masking Description
Nil, however, Outcomes Assessor will be blinded to study hypothesis.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All adult laypersons (Aged 18 years or older)
- •Able to communicate in English (to sign informed consent)
Exclusion Criteria
- •Physical disability limiting the performance/use of the interventions
- •Individuals with healthcare training (e.g., physicians, nurses, paramedics, respiratory therapists or associated students)
Arms & Interventions
LV - DC - AT
Order: LifeVac then Dechoker then Abdominal Thrusts
Intervention: Dechoker (Other)
LV - DC - AT
Order: LifeVac then Dechoker then Abdominal Thrusts
Intervention: LifeVac (Other)
LV - DC - AT
Order: LifeVac then Dechoker then Abdominal Thrusts
Intervention: Abdominal Thrusts (Other)
LV - AT - DC
Order: LifeVac then Abdominal Thrusts then Dechoker
Intervention: LifeVac (Other)
LV - AT - DC
Order: LifeVac then Abdominal Thrusts then Dechoker
Intervention: Abdominal Thrusts (Other)
LV - AT - DC
Order: LifeVac then Abdominal Thrusts then Dechoker
Intervention: Dechoker (Other)
DC - AT - LV
Order: Dechoker then Abdominal Thrusts then LifeVac
Intervention: Dechoker (Other)
DC - AT - LV
Order: Dechoker then Abdominal Thrusts then LifeVac
Intervention: LifeVac (Other)
DC - AT - LV
Order: Dechoker then Abdominal Thrusts then LifeVac
Intervention: Abdominal Thrusts (Other)
DC - LV - AT
Order: Dechoker then LifeVac then Abdominal Thrusts
Intervention: Dechoker (Other)
DC - LV - AT
Order: Dechoker then LifeVac then Abdominal Thrusts
Intervention: LifeVac (Other)
DC - LV - AT
Order: Dechoker then LifeVac then Abdominal Thrusts
Intervention: Abdominal Thrusts (Other)
AT - LV - DC
Order: Abdominal Thrusts then LifeVac then Dechoker
Intervention: Dechoker (Other)
AT - LV - DC
Order: Abdominal Thrusts then LifeVac then Dechoker
Intervention: LifeVac (Other)
AT - LV - DC
Order: Abdominal Thrusts then LifeVac then Dechoker
Intervention: Abdominal Thrusts (Other)
AT - DC - LV
Order: Abdominal Thrusts then Dechoker then LifeVac
Intervention: Dechoker (Other)
AT - DC - LV
Order: Abdominal Thrusts then Dechoker then LifeVac
Intervention: LifeVac (Other)
AT - DC - LV
Order: Abdominal Thrusts then Dechoker then LifeVac
Intervention: Abdominal Thrusts (Other)
Outcomes
Primary Outcomes
Odds Ratio of Airway Obstruction Relief Within One-Minute
Time Frame: 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.
Secondary Outcomes
- Odds Ratio of Airway Obstruction Relief Within Four-Minutes(4 minutes)
- Hazard Ratio of Time to Airway Obstruction Relief (Retention Testing)(Maximal time allotted is 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)