Evaluation of Foreign Body Airway Obstruction Interventions Through Simulation

NCT06227234 | Completed

• 1 other identifier: REB23-1548
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Obstruction; Choking

Keywords

Basic Life Support; Foreign body airway obstruction; Abdominal thrusts; Layperson; Airway Clearance Device; Lifevac; Dechoker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 One-Minute (Retention Testing)

  1 minute

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

  4 minutes

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

  Maximal time allotted is 4 minutes

Study Arms (6)

LV - DC - AT

EXPERIMENTAL

Order: LifeVac then Dechoker then Abdominal Thrusts

Other: Dechoker; Other: LifeVac; Other: Abdominal Thrusts

LV - AT - DC

EXPERIMENTAL

Order: LifeVac then Abdominal Thrusts then Dechoker

Other: Dechoker; Other: LifeVac; Other: Abdominal Thrusts

DC - AT - LV

EXPERIMENTAL

Order: Dechoker then Abdominal Thrusts then LifeVac

Other: Dechoker; Other: LifeVac; Other: Abdominal Thrusts

DC - LV - AT

EXPERIMENTAL

Order: Dechoker then LifeVac then Abdominal Thrusts

Other: Dechoker; Other: LifeVac; Other: Abdominal Thrusts

AT - LV - DC

EXPERIMENTAL

Order: Abdominal Thrusts then LifeVac then Dechoker

Other: Dechoker; Other: LifeVac; Other: Abdominal Thrusts

AT - DC - LV

EXPERIMENTAL

Order: Abdominal Thrusts then Dechoker then LifeVac

Other: Dechoker; Other: LifeVac; Other: Abdominal Thrusts

Interventions

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.

AT - DC - LV; AT - LV - DC; DC - AT - LV; DC - LV - AT; LV - AT - DC; LV - DC - AT

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.

AT - DC - LV; AT - LV - DC; DC - AT - LV; DC - LV - AT; LV - AT - DC; LV - DC - AT

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.

AT - DC - LV; AT - LV - DC; DC - AT - LV; DC - LV - AT; LV - AT - DC; LV - DC - AT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Physical disability limiting the performance/use of the interventions
• Individuals with healthcare training (e.g., physicians, nurses, paramedics, respiratory therapists or associated students)

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Association of Emergency Physicians: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, Canada

Location

Related Publications (1)

• 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.

  PMID: 41362661 DERIVED

MeSH Terms

Conditions

Airway Obstruction

Interventions

Heimlich Maneuver

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Emergency Treatment; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Nil, however, Outcomes Assessor will be blinded to study hypothesis.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: August 7, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 29, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon request.

Locations

CA (1)