Foreign Body Airway ObstructionNCT07348848
Prospective Evaluation of Foreign Body Airway Obstruction Interventions Among Infants
An observational study of Foreign Body Airway Obstruction, 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
- Foreign Body Airway Obstruction
- What is being tested?
- Chest compressions/thrusts, Back blows and Abdominal Thrusts
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2025to 30 Jun 2026
- Phase
- Observational
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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
Who cannot join
- Patients with abnormal airway anatomy such as a tracheostomy.
- Patients who were unconscious when they received the initial FBAO intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Foreign Body Airway Obstruction
- Being tested
- Chest compressions/thrusts, Back blows, Abdominal Thrusts
- Keywords
- Choking, Infants, Prospective cohort, Feasibility
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest compressions/thrustsProcedure or surgery
Chest compressions or thrusts received as first intervention
Back blowsProcedure or surgery
Back blows received as first intervention
Abdominal ThrustsProcedure or surgery
Abdominal thrusts received as first intervention
| Study group | Role | What they receive |
|---|---|---|
| Infants with FBAO | Infants (aged 2 years or younger) with a foreign body airway obstruction who are conscious when they receive their first intervention Receives: Procedure: Chest compressions/thrusts; Procedure: Back blows; Procedure: Abdominal Thrusts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligible patient recruitment
Count of eligible patients recruited per month
Measured: Through study completion, a 6 month period
Secondary outcomes (6)
Proportion of eligible patients recruited
Among patients who screen as eligible for recruitment, the proportion of those who are successfully recruited
Measured: Through study completion, a 6 month period
Proportion of recruited patients with satisfactory data collection
Among patients successfully recruited, the those patients with >= 90% of desired variables collected
Measured: Through study completion, a 6 month period
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
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 month
Survival to acute care discharge with favourable neurological outcome
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
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 month
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 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Nov 2025
- Primary completion30 Apr 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foreign Body Airway ObstructionStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cody Dunne, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348848
- Sponsor's protocol ID
- REB25-0419B
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2025
- Last updated
- 9 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Foreign Body Airway Obstruction Interventions Among Infants: A Non-randomized Pilot Cohort Study
- ClinicalTrials.gov ID
- NCT07348848
- Acronym / sponsor ID
- REB25-0419B
- Conditions
- Foreign Body Airway Obstruction
- Keywords
- Choking, Infants, Prospective cohort, Feasibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 16 Jan 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. 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants with FBAO | – | Procedure: Chest compressions/thrusts, Procedure: Back blows, Procedure: Abdominal ThrustsInfants (aged 2 years or younger) with a foreign body airway obstruction who are conscious when they receive their first intervention |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with abnormal airway anatomy such as a tracheostomy.
- Patients who were unconscious when they received the initial FBAO intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest compressions/thrustsChest compressions or thrusts received as first intervention | Procedure or surgery | Infants with FBAO |
| Back blowsBack blows received as first intervention | Procedure or surgery | Infants with FBAO |
| Abdominal ThrustsAbdominal thrusts received as first intervention | Procedure or surgery | Infants with FBAO |
Primary outcome
Eligible patient recruitment
Time frame: Through study completion, a 6 month period
Count of eligible patients recruited per month
6 secondary outcomes
Proportion of eligible patients recruited
Time frame: Through study completion, a 6 month period
Proportion of recruited patients with satisfactory data collection
Time frame: Through study completion, a 6 month period
Foreign body airway obstruction relief
Time frame: 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Foreign Body 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 9 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?
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?
Eligible patient recruitment (time frame: Through study completion, a 6 month period). 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 9 Sep 2026.