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.

Study Overview

• Status: Completed
• Conditions: Airway Obstruction; Choking
• Intervention / Treatment: Other: Dechoker; Other: LifeVac; Other: Abdominal Thrusts

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LV - DC - AT; Order: LifeVac then Dechoker then Abdominal Thrusts	Other: Dechoker; 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.; Other: LifeVac; 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.; Other: Abdominal Thrusts; 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.
Experimental: LV - AT - DC; Order: LifeVac then Abdominal Thrusts then Dechoker	Other: Dechoker; 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.; Other: LifeVac; 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.; Other: Abdominal Thrusts; 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.
Experimental: DC - AT - LV; Order: Dechoker then Abdominal Thrusts then LifeVac	Other: Dechoker; 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.; Other: LifeVac; 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.; Other: Abdominal Thrusts; 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.
Experimental: DC - LV - AT; Order: Dechoker then LifeVac then Abdominal Thrusts	Other: Dechoker; 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.; Other: LifeVac; 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.; Other: Abdominal Thrusts; 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.
Experimental: AT - LV - DC; Order: Abdominal Thrusts then LifeVac then Dechoker	Other: Dechoker; 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.; Other: LifeVac; 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.; Other: Abdominal Thrusts; 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.
Experimental: AT - DC - LV; Order: Abdominal Thrusts then Dechoker then LifeVac	Other: Dechoker; 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.; Other: LifeVac; 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.; Other: Abdominal Thrusts; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Odds Ratio of Airway Obstruction Relief Within One-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.	1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Odds Ratio of Airway Obstruction Relief Within Four-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.	4 minutes
Hazard Ratio of Time to Airway Obstruction Relief	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.	Maximal time allotted is 4 minutes
Odds Ratio of Airway Obstruction Relief Within One-Minute (Retention Testing)	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.	1 minute
Odds Ratio of Airway Obstruction Relief Within Four-Minutes (Retention Testing)	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 minutes
Hazard Ratio of Time to Airway Obstruction Relief (Retention Testing)	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.	Maximal time allotted is 4 minutes

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Canadian Association of Emergency Physicians

Publications and helpful links

General Publications

• Dunne CL, Mannani N, Cirone J, Cheng A, Blanchard IE, Holroyd-Leduc J, Wilson TA, Sauro K, McRae AD. Comparison of foreign body airway obstruction interventions among laypersons: A simulation-based, crossover, randomized controlled trial. Resusc Plus. 2025 Nov 10;26:101156. doi: 10.1016/j.resplu.2025.101156. eCollection 2025 Nov.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Basic Life Support; Layperson; Foreign body airway obstruction; Abdominal thrusts; Airway Clearance Device; Lifevac; Dechoker
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction; Therapeutics; Emergency Treatment; Heimlich Maneuver
• Other Study ID Numbers: REB23-1548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will be available upon request.
• IPD Sharing Time Frame: Upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes