Determining the Effectiveness of Counterpressure Maneuvers in Pediatric Patients Presenting With Syncope to the Emergency Department

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The investigators will assess the efficacy of clinically recommended counterpressure maneuvers (CPM) in preventing syncope for paediatric patients. Participants presenting to the emergency department (ED) will first provide written informed consent. In stage I, they will be asked to complete a brief survey documenting the presentation of their syncopal episode, and any prodromal symptoms they experienced. Participants that consent to the second stage of the study will either receive usual care (control arm) or training in counter pressure maneuvers alongside usual care (intervention arm; leg crossing, bending, arm tensing). These patients will be followed for one years time, and will be asked to complete monthly surveys detailing their syncopal and presyncopal recurrence. Medical records will be accessed over the duration of the study to identify any changes in medical diagnosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: No
View:

• Those between the ages of 6-18 years (inclusive)

• Presenting to the ED daily 1000-2200 with resolved transient loss of consciousness that has occurred within the last week

• Able to complete the survey in English

• Willing and able to provide consent and assent

Locations
Other Locations
Canada
BC Children's Hospital
Recruiting
Vancouver
Contact Information
Primary
Erin L Williams, BSc
erin_williams_2@sfu.ca
6048976372
Backup
Sonia Franciosi, PhD
Sonia.Franciosi@cw.bc.ca
(604) 875-2345
Time Frame
Start Date: September 3, 2022
Estimated Completion Date: September 30, 2024
Participants
Target number of participants: 300
Treatments
Experimental: Counterpressure Maneuvers
Participants will receive standard of care treatment (behavioural intervention and avoidance measures, as indicated in Usual Care), alongside training in counter pressure maneuvers. Training in counterpressure maneuvers will be delivered through a handout and video that will show three maneuvers (i.e. arm-tensing, squatting, and leg-crossing) that patients enrolled in the intervention arm can perform when they begin to experience common signs and symptoms of syncope. Patients will be instructed to start with one of the maneuvers and if their symptoms do not go away, move on to a second or third maneuver if needed.
Active Comparator: Usual Care
Participants will receive standard of care treatment for their diagnosis of syncope. This primarily includes behavioural interventions and avoidance measures (e.g., stay hydrated, increase salt intake, avoid hot situations, avoid standing for long periods of time, engage in regular physical activity). Some patients may be prescribed medication (Midodrine, Fludrocortisone) at the discretion of their physician.
Sponsors
Collaborators: Provincial Health Services Authority, University of British Columbia, Simon Fraser University
Leads: Dr. Victoria Claydon

This content was sourced from clinicaltrials.gov

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