Paediatric Syncope in the Emergency Department

NCT05555771 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Syncope, Vasovagal
  • Postural Orthostatic Tachycardia Syndrome
  • Orthostatic Intolerance

Interventions

BEHAVIORAL

Counterpressure Maneuvers

Movements that can aid in delaying or preventing syncope by recruiting skeletal muscle pumping (via compression of major veins by contracting muscle to eject blood through cardiovascular circuit) and increased sympathetic drive (via sustaining an isometric muscle contraction). In this trial, we will be evaluating three commonly recommended maneuvers of arm tensing, squatting, and leg crossing with arm tensing. Maneuvers should be held for 1-2 minutes, or until symptoms subside.

BEHAVIORAL

Usual Care

Participants will engage in behavioural interventions and avoidance measures that are commonly recommended as a part of usual care for recurrent syncope. This primarily includes recommendations such as staying hydrated, increasing salt intake, avoiding warm temperatures, avoiding standing for long periods of time, and engaging in regular physical activity. Some patients may be prescribed medication (Midodrine, Fludrocortisone), or other assistive interventions (e.g., compression stockings) at the discretion of their physician.

Sponsors & Collaborators

  • Provincial Health Services Authority British Columbia

    collaborator OTHER
  • University of British Columbia

    collaborator OTHER
  • Simon Fraser University

    collaborator OTHER
  • Dr. Victoria Claydon

    lead OTHER

Principal Investigators

  • Shubhayan Sanatani, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-03
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05555771 on ClinicalTrials.gov