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Prospective Evaluation of Foreign Body Airway Obstruction Interventions Among Infants

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07348848
Enrollment
39
Registered
2026-01-16
Start date
2025-11-01
Completion date
2026-06-30
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foreign Body Airway Obstruction

Keywords

Choking, Infants, Prospective cohort, Feasibility

Brief 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. 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.

Interventions

Chest compressions or thrusts received as first intervention

PROCEDUREBack blows

Back blows received as first intervention

Abdominal thrusts received as first intervention

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Eligible patient recruitmentThrough study completion, a 6 month periodCount of eligible patients recruited per month

Secondary

MeasureTime frameDescription
Proportion of eligible patients recruitedThrough study completion, a 6 month periodAmong patients who screen as eligible for recruitment, the proportion of those who are successfully recruited
Proportion of recruited patients with satisfactory data collectionThrough study completion, a 6 month periodAmong patients successfully recruited, the those patients with \>= 90% of desired variables collected
Foreign body airway obstruction reliefDay 1Defined 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
Survival to acute care dischargeFrom date of enrolment until the date of acute care discharge or date of death from any cause, whichever came first, assessed up to 3 monthDefined as discharge from the care of Emergency Medical Services(EMS) or paramedics, the emergency department, or the hospital.
Survival to acute care discharge with favourable neurological outcomeFrom date of enrolment until the date of acute care discharge or date of death from any cause, whichever came first, assessed up to 3 monthDefined 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
Intervention-associated injuriesFrom date of enrolment until the date of acute care discharge or date of death from any cause, whichever came first, assessed up to 3 monthListed 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026