Clinical trial NCT06227234: Evaluation of Foreign Body Airway Obstruction Interventions Through Simulation
Official title: Evaluation of Foreign Body Airway Obstruction Interventions Through Simulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Choking
Airway Obstruction
Keywords: Basic Life Support
Foreign body airway obstruction
Abdominal thrusts
Layperson
Airway Clearance Device
Lifevac
Dechoker
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Association of Emergency Physicians
First posted: 2024-01-26
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Investigators will conduct an open-label, crossover, mannequin, randomized controlled trial to compare two airway clearance devices (LifeVac© and Dechoker©) with traditional abdominal thrusts as choking interventions. Participants will complete all through interventions in one of 6 randomized orders.
Primary purpose: OTHER

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.

Methods Investigators will conduct an open-label, crossover, mannequin, randomized controlled trial to compare two ACDs (LifeVac© and Dechoker©) with traditional abdominal thrusts as FBAO interventions.

Randomization: Using OnCore randomization service to 1 of 6 intervention orders. Randomization will be performed by a researcher not involved with participant recruitment, and allocation will be concealed until enrollment using OnCore software as well.

Pre-simulation: Prior to any intervention, each participant will receive an orientation to the simulator (Choking Charlie, Laerdal Medical AS, Stavanger, Norway), environment, and the outcomes being assessed. A member of the research team will be available to answer any questions that they have prior to starting.

Intervention: Participants will be shown the manufacturer's (LifeVac© and Dechoker©) recommended short educational video for each intervention. A publicly available online instructional video, prepared by St John Ambulance, will be used for abdominal thrusts. Immediately after watching the first training video in their allocated sequence, participants will be asked to respond to a FBAO scenario, using the assigned technique. Participants will have up to four minutes to complete the intervention. All intervention attempts will be video recorded from a standardized position. Each participant will repeat the process (instructional video, followed by scenario) two more times so that they attempt each intervention. Participants will have a short break (of approximately two minutes) between each intervention.

Follow Up: All participants will be invited back between 90 - 120 days to complete the same scenario with the 3 interventions again to assess skills retention.

Eligibility criteria: Inclusion Criteria:

* All adult laypersons (Aged 18 years or older)
* Able to communicate in English (to sign informed consent)
* Non-

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)

Primary outcomes:
measure: Odds Ratio of Airway Obstruction Relief Within One-Minute
timeFrame: 1 minute
Secondary outcomes:
measure: Odds Ratio of Airway Obstruction Relief Within Four-Minutes
timeFrame: 4 minutes
measure: Hazard Ratio of Time to Airway Obstruction Relief
timeFrame: Maximal time allotted is 4 minutes
measure: Odds Ratio of Airway Obstruction Relief Within One-Minute (Retention Testing)
timeFrame: 1 minute
measure: Odds Ratio of Airway Obstruction Relief Within Four-Minutes (Retention Testing)
timeFrame: 4 minutes
measure: Hazard Ratio of Time to Airway Obstruction Relief (Retention Testing)
timeFrame: Maximal time allotted is 4 minutes
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
References: