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Postural Sway and Counterpressure Maneuvers for Pediatric Syncope

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: May 2025 to May 2027
    • Study completion date: Jun 2025 to Jun 2027
    v4
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: May 2023 to May 2025
    • Study sites: 0 to 1
    • Study completion date: Jun 2023 to Jun 2025
    • Start date changed from estimate of Jan 2023 to Apr 17, 2023
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The investigators are interested in whether discrete counterpressure maneuvers, or muscle movements in the lower body, will boost blood pressure and cardiovascular control in children who faint. We will record cardiovascular responses to maneuvers of exaggerated sway, leg crossing, crouching, and gluteal muscle tensing in children who faint (N=20), as well as their height, weight, muscularity, and pubertal (Tanner) stage. Autonomic cardiovascular control will be measured using a Valsalva manoeuvre (expiration against a closed airway for 20 seconds) and a supine-stand test. The primary outcomes are noninvasive measures of cardiovascular responses to the maneuvers (blood pressure, cerebral blood flow, and stroke volume (volume of blood pumped per heartbeat). Comparisons will be made across levels of sex, diagnosis, Tanner stage, muscularity, height, and degree of autonomic control.
Trial Details
NCT Number NCT05633693
Lead Sponsor Simon Fraser University
Collaborators: Provincial Health Services Authority British Columbia, University of British Columbia, Natural Sciences and Engineering Research Council, Canada
Conditions
(from sponsor)
Syncope, Vasovagal, Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance
Related terms Orthostatic Intolerance, Postural Orthostatic Tachycardia Syndrome, Syncope, Vasovagal
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov