Evaluation of Foreign Body Airway Obstruction Interventions: A Prospective Cohort Study of Adults and Children
ConditionChoking
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3+
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 adults and children over the age of 2 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult or children (aged greater than 2 years) 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
Adult or children (aged greater than 2 years) 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
640 Participants
are grouped into 5 trial groupsGroup A: Abdominal thrust
Group B: Back blows
Group C: Chest thrusts on conscious individual
Group D: CPR on unconscious individual
Group E: LifeVac airway clearance device
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 1Secondary 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 month2
Survival to acute care discharge with favourable neurological outcome
Defined as no change in baseline neurological function (measured using 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 months3
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov