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ChokingNCT06227234

Evaluation of Foreign Body Airway Obstruction Interventions Through Simulation

A study testing Dechoker, LifeVac and Abdominal Thrusts in people with Choking and Airway Obstruction, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Choking, Airway Obstruction
What is being tested?
Dechoker, LifeVac and Abdominal Thrusts
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteCanada
Study dates
7 Aug 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Calgary

    Calgary, Alberta

Other trials in Canada

About this study

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.

Read more

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.

Read the 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.

Being tested
Dechoker, LifeVac, Abdominal Thrusts
Keywords
Basic Life Support, Foreign body airway obstruction, Abdominal thrusts, Layperson, Airway Clearance Device, Lifevac, Dechoker
Medical subject headings
Airway Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DechokerOther

    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.

  • LifeVacOther

    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 ThrustsOther

    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.

Study groups in NCT06227234
Study groupRoleWhat they receive
LV - DC - ATExperimentalOrder: LifeVac then Dechoker then Abdominal Thrusts
Receives: Other: Dechoker; Other: LifeVac; Other: Abdominal Thrusts
LV - AT - DCExperimentalOrder: LifeVac then Abdominal Thrusts then Dechoker
Receives: Other: Dechoker; Other: LifeVac; Other: Abdominal Thrusts
DC - AT - LVExperimentalOrder: Dechoker then Abdominal Thrusts then LifeVac
Receives: Other: Dechoker; Other: LifeVac; Other: Abdominal Thrusts
DC - LV - ATExperimentalOrder: Dechoker then LifeVac then Abdominal Thrusts
Receives: Other: Dechoker; Other: LifeVac; Other: Abdominal Thrusts
AT - LV - DCExperimentalOrder: Abdominal Thrusts then LifeVac then Dechoker
Receives: Other: Dechoker; Other: LifeVac; Other: Abdominal Thrusts
AT - DC - LVExperimentalOrder: Abdominal Thrusts then Dechoker then LifeVac
Receives: Other: Dechoker; Other: LifeVac; Other: Abdominal Thrusts

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 minute

Secondary outcomes (5)
  1. 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.

    Measured: 4 minutes

  2. 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.

    Measured: Maximal time allotted is 4 minutes

  3. 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.

    Measured: 1 minute

  4. 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.

    Measured: 4 minutes

  5. 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.

    Measured: Maximal time allotted is 4 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2024
  2. Study start7 Aug 2024
  3. Primary completion30 Jun 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
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.
Masking
None (open label)
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06227234
Sponsor's protocol ID
REB23-1548
Status last verified
Mar 2025
First submitted
17 Jan 2024
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Will be available upon request.

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.

    PubMed 41362661

Questions about this trial

What is this clinical trial studying?

A study testing Dechoker, LifeVac and Abdominal Thrusts in people with Choking and Airway Obstruction, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Odds Ratio of Airway Obstruction Relief Within One-Minute (time frame: 1 minute). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06227234, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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