Prospective Evaluation of Foreign Body Airway Obstruction Interventions Among Infants

January 9, 2026 updated by: Cody Dunne, University of Calgary

Prospective Evaluation of Foreign Body Airway Obstruction Interventions Among Infants: A Non-randomized Pilot Cohort Study

Foreign body airway obstruction (FBAO, choking) is a life-threatening emergency requiring time-sensitive treatment to prevent severe injury or deaths. Traditional treatments taught in first aid courses include abdominal thrusts, back blows, and chest compressions or thrusts. Currently, first aid guidelines recommend different treatments for adults, child and infants.

Until recently, data on these techniques was limited to case series from the late 1900's. To further improve our knowledge of which treatment is most effective and safest for patients, this study will collect data on choking incidents in Alberta, Canada. The first phase of this project will make sure identifying and recruiting choking patients in real-time is possible so that the highest quality of data can be collected. If successful, this study will support a future project where the different choking treatments are compared in terms of their effectiveness and safety. This study will focus on infants aged 2 years or younger.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Infants (aged 2 years or less) who experienced an out-of-hospital FBAO and received a FBAO intervention while conscious in Alberta, Canada, and, subsequently, were assessed by EMS or at an emergency department

Description

Inclusion Criteria:

  • Infants (aged 2 years or less) who experienced an out-of-hospital FBAO in Alberta, Canada
  • Received a FBAO intervention while conscious by bystander or healthcare provider
  • Were assessed by EMS at the time of the incident, or later attended an emergency department due to the incident

Exclusion Criteria:

  • Patients with abnormal airway anatomy such as a tracheostomy.
  • Patients who were unconscious when they received the initial FBAO intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infants with FBAO
Infants (aged 2 years or younger) with a foreign body airway obstruction who are conscious when they receive their first intervention
Procedure: Chest compressions/thrusts
Chest compressions or thrusts received as first intervention
Procedure: Back blows
Back blows received as first intervention
Procedure: Abdominal Thrusts
Abdominal thrusts received as first intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eligible patient recruitment
Time Frame: Through study completion, a 6 month period
Count of eligible patients recruited per month
Through study completion, a 6 month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eligible patients recruited
Time Frame: Through study completion, a 6 month period
Among patients who screen as eligible for recruitment, the proportion of those who are successfully recruited
Through study completion, a 6 month period
Proportion of recruited patients with satisfactory data collection
Time Frame: Through study completion, a 6 month period
Among patients successfully recruited, the those patients with >= 90% of desired variables collected
Through study completion, a 6 month period
Foreign body airway obstruction relief
Time Frame: Day 1
Defined as: responders determining that the patient did not require further FBAO intervention due to improvement or resolution of their respiratory distress in a conscious patient, or the ability for a responder to successfully ventilate an unconscious patient when previously they were unable to due to obstruction
Day 1
Survival to acute care discharge
Time Frame: From date of enrolment until the date of acute care discharge or date of death from any cause, whichever came first, assessed up to 3 month
Defined as discharge from the care of Emergency Medical Services(EMS) or paramedics, the emergency department, or the hospital.
From date of enrolment until the date of acute care discharge or date of death from any cause, whichever came first, assessed up to 3 month
Survival to acute care discharge with favourable neurological outcome
Time Frame: From date of enrolment until the date of acute care discharge or date of death from any cause, whichever came first, assessed up to 3 month
Defined as the patient being able to be discharge to the home environment that they previously lived, with the ability to perform the same activities of daily living as before the FBAO incident
From date of enrolment until the date of acute care discharge or date of death from any cause, whichever came first, assessed up to 3 month
Intervention-associated injuries
Time Frame: From date of enrolment until the date of acute care discharge or date of death from any cause, whichever came first, assessed up to 3 month
Listed summary of any injuries reported among patient recruited for study occurring as a result of the FBAO intervention as determined by the treating physician/care provider
From date of enrolment until the date of acute care discharge or date of death from any cause, whichever came first, assessed up to 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 29, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB25-0419B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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