Health TrialsbyHealthPanel

Evaluation of Foreign Body Airway Obstruction Interventions Among Young Children: A Prospective Cohort Study

ConditionChoking
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 2
SponsorUniversity of Calgary

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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

Disqualifiers

None

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

381 Participants
are grouped into 5 trial groups
Group A: Abdominal thrusts
Group B: Back blows
Group C: LifeVac airway clearance device
Group D: Chest thrusts or compressions on conscious individual
Group E: CPR on unconscious individual

Trial outcomes

Primary outcomes

1

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

Time frame
Day 1

Secondary outcomes

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.

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
2

Survival to acute care discharge with favourable neurological outcome

Defined as no change from baseline neurological function as measured by the Cerebral Performance Category

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
3

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Source ClinicalTrials.gov
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