- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07814690
Evaluation of Foreign Body Airway Obstruction Interventions: A Prospective Cohort Study of Adults and Children
September 5, 2026 updated by: Cody Dunne, University of Calgary
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.
This study will focus on adults and children over the age of 2 years.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
640
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
- Name: Cody Dunne, MD
- Phone Number: 000-000-0000
- Email: cody.dunne@ucalgary.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada
- Recruiting
- Virtual
-
Contact:
- Cody Dunne, MD
- Phone Number: 000-000-0000
- Email: cody.dunne@ucalgary.ca
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult or children (aged greater than 2 years) who experienced an out-of-hospital FBAO and received a FBAO intervention in Alberta, Canada, and, subsequently, were assessed by EMS or at an emergency department
Description
Inclusion Criteria:
- Adult or children (aged greater than 2 years) who experienced an out-of-hospital FBAO in Alberta, Canada
- Received a FBAO intervention 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.
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 |
|---|
|
Abdominal thrust
|
|
Back blows
|
|
Chest thrusts on conscious individual
|
|
CPR on unconscious individual
|
|
LifeVac airway clearance device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 months
|
Defined as no change in baseline neurological function (measured using the Cerebral Performance Category)
|
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 months
|
|
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 months
|
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 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cody Dunne, MD, 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)
May 1, 2026
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
December 31, 2030
Study Registration Dates
First Submitted
September 5, 2026
First Submitted That Met QC Criteria
September 5, 2026
First Posted (Actual)
September 11, 2026
Study Record Updates
Last Update Posted (Actual)
September 11, 2026
Last Update Submitted That Met QC Criteria
September 5, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB25-0419
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.