- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07365137
Prospective Evaluation of Foreign Body Airway Obstruction Interventions Among Adults and Children
Prospective Evaluation of Foreign Body Airway Obstruction Interventions Among Adults and Children: 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 adults and children over the age of 2 years.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Cody Dunne, MD
- Phone Number: 1-403-944-1818
- 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
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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 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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adults or children with FBAO
Adults or children (aged greater than 2 years) with a foreign body airway obstruction who are conscious when they receive their first intervention
|
Chest compressions or thrusts received as first intervention
Back blows received as first intervention
Abdominal thrust 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
Sponsor
Investigators
- Principal Investigator: Cody Dunne, MD, University of Calgary
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB25-0419A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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-
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