Evaluation of Foreign Body Airway Obstruction Interventions Through Simulation

U

University of Calgary

Status

Begins enrollment this month

Conditions

Choking
Airway Obstruction

Treatments

Other: LifeVac
Other: Abdominal Thrusts
Other: Dechoker

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06227234
REB23-1548

Details and patient eligibility

About

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 who have not completed prior training on any of the devices or techniques within 5 years, or used them in real life. 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.

Full 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.

Enrollment

132 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Aged 18 years or older
  • Able to communicate in English (to sign informed consent)

Exclusion criteria

  • Physical disability limiting the performance/use of the interventions
  • Prior use of any of the interventions on a human
  • Prior training on any of the interventions within the last 5 years.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

132 participants in 6 patient groups

LV - DC - AT
Experimental group
Description:
Order: LifeVac then Dechoker then Abdominal Thrusts
Treatment:
Other: Dechoker
Other: Abdominal Thrusts
Other: LifeVac
LV - AT - DC
Experimental group
Description:
Order: LifeVac then Abdominal Thrusts then Dechoker
Treatment:
Other: Dechoker
Other: Abdominal Thrusts
Other: LifeVac
DC - AT - LV
Experimental group
Description:
Order: Dechoker then Abdominal Thrusts then LifeVac
Treatment:
Other: Dechoker
Other: Abdominal Thrusts
Other: LifeVac
DC - LV - AT
Experimental group
Description:
Order: Dechoker then LifeVac then Abdominal Thrusts
Treatment:
Other: Dechoker
Other: Abdominal Thrusts
Other: LifeVac
AT - LV - DC
Experimental group
Description:
Order: Abdominal Thrusts then LifeVac then Dechoker
Treatment:
Other: Dechoker
Other: Abdominal Thrusts
Other: LifeVac
AT - DC - LV
Experimental group
Description:
Order: Abdominal Thrusts then Dechoker then LifeVac
Treatment:
Other: Dechoker
Other: Abdominal Thrusts
Other: LifeVac

Trial contacts and locations

0

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Central trial contact

Cody Dunne, MD

Data sourced from clinicaltrials.gov

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