ChokingNCT07817693
Evaluation of Foreign Body Airway Obstruction Interventions Among Young Children: A Prospective Cohort Study
An observational study of Choking, run by University of Calgary at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Choking
- How many people
- 381 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2026to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Young children (aged 2 years or less) 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
Who may be able to join
- - Young children (aged 2 years or less) 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
Who cannot join
- Patients with abnormal airway anatomy such as a tracheostomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Virtual
Calgary, Alberta
Cody Dunne, MD, 000-000-0000, cody.dunne@ucalgary.ca
About this 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. This study will focus on infants aged 2 years or younger.
- Conditions
- Choking
- Keywords
- Foreign body airway obstruction, Basic life support
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal thrusts | Abdominal thrusts | |
| Back blows | Back blows | |
| LifeVac airway clearance device | LifeVac airway clearance device | |
| Chest thrusts or compressions on conscious individual | Chest thrusts or compressions on conscious individual | |
| CPR on unconscious individual | CPR on unconscious individual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foreign body airway obstruction relief
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
Measured: Day 1
Secondary outcomes (3)
Survival to acute care discharge
Defined as discharge from the care of Emergency Medical Services (EMS) or paramedics, the emergency department, or the hospital.
Measured: 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
Survival to acute care discharge with favourable neurological outcome
Defined as no change from baseline neurological function as measured by the Cerebral Performance Category
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 May 2026
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChokingStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 381 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cody Dunne, University of Calgary
- Investigators
- Cody Dunne, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817693
- Sponsor's protocol ID
- REB25-0419_b
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Foreign Body Airway Obstruction Interventions Among Young Children: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07817693
- Acronym / sponsor ID
- REB25-0419_b
- Conditions
- Choking
- Keywords
- Foreign body airway obstruction, Basic life support
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 381 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 infants aged 2 years or younger.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Abdominal thrusts | – | –Abdominal thrusts |
| Back blows | – | –Back blows |
| LifeVac airway clearance device | – | –LifeVac airway clearance device |
| Chest thrusts or compressions on conscious individual | – | –Chest thrusts or compressions on conscious individual |
| CPR on unconscious individual | – | –CPR on unconscious individual |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Young children (aged 2 years or less) 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
Key inclusion criteria (3 listed)
- - Young children (aged 2 years or less) 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
Key exclusion criteria (1 listed)
- Patients with abnormal airway anatomy such as a tracheostomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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 months
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cody Dunne, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choking, 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 1 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: looking for participants now, as of the sponsor's last update on 14 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cody Dunne (000-000-0000, cody.dunne@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foreign body airway obstruction relief (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.