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OpenTrials
Completed

NCT Number: NCT06227234

Evaluation of Foreign Body Airway Obstruction Interventions Through Simulation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, Canada

About this study

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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dechoker

Other

Participants will be shown a short educational video for each intervention. A research assistant acting as an instructor will be present to answer any questions that the students have about each of the techniques.

After training of all three techniques is complete, participants will be asked to respond to a choking scenario, using an assigned technique (the first one in their randomized order). Participants will use a mannequin (Choking Charlie, Laerdal Medical AS, Stavanger, Norway), with a simulated food bolus placed per manufacturer's directions, to complete each scenario. Participants will have up to four minutes to complete the intervention.

Each participant will repeat the two more times so that they attempt each intervention.

LifeVac

Other

Participants will be shown a short educational video for each intervention. A research assistant acting as an instructor will be present to answer any questions that the students have about each of the techniques.

After training of all three techniques is complete, participants will be asked to respond to a choking scenario, using an assigned technique (the first one in their randomized order). Participants will use a mannequin (Choking Charlie, Laerdal Medical AS, Stavanger, Norway), with a simulated food bolus placed per manufacturer's directions, to complete each scenario. Participants will have up to four minutes to complete the intervention.

Each participant will repeat the two more times so that they attempt each intervention.

Abdominal Thrusts

Other

Participants will be shown a short educational video for each intervention. A research assistant acting as an instructor will be present to answer any questions that the students have about each of the techniques.

After training of all three techniques is complete, participants will be asked to respond to a choking scenario, using an assigned technique (the first one in their randomized order). Participants will use a mannequin (Choking Charlie, Laerdal Medical AS, Stavanger, Norway), with a simulated food bolus placed per manufacturer's directions, to complete each scenario. Participants will have up to four minutes to complete the intervention.

Each participant will repeat the two more times so that they attempt each intervention.

Primary outcomes

  1. 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

  1. Odds Ratio of Airway Obstruction Relief Within Four-Minutes

    Time frame: 4 minutes

    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.

  2. Hazard Ratio of Time to Airway Obstruction Relief

    Time frame: Maximal time allotted is 4 minutes

    This outcome will be calculated using a mixed-effect Cox 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.

  3. Odds Ratio of Airway Obstruction Relief Within One-Minute (Retention Testing)

    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. Retention testing will occur between 90-120 days. Comparison will be made between different pairs of devices.

  4. Odds Ratio of Airway Obstruction Relief Within Four-Minutes (Retention Testing)

    Time frame: 4 minutes

    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. Retention testing will occur between 90-120 days. Comparison will be made between different pairs of devices.

  5. Hazard Ratio of Time to Airway Obstruction Relief (Retention Testing)

    Time frame: Maximal time allotted is 4 minutes

    This outcome will be calculated using a mixed-effect Cox 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. Participants will return for re-testing of skills between 90-120 days. Comparison will be made between different pairs of devices.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Canadian Association of Emergency Physicians

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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