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Not Yet Recruiting NCT05633693

Postural Sway and Counterpressure Maneuvers for Pediatric Syncope

Conditions: Syncope, Vasovagal, Postural Orthostatic Tachycardia Syndrome, Orthostatic Intolerance

Sex: All
Ages: 6 Years – 18 Years
Phase: NA
Enrollment: 30
Sponsor: Simon Fraser University

Summary

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.

Eligibility Criteria

Inclusion Criteria:We are looking for English speaking pediatric patients aged 6-18 years with a diagnosis of recurrent fainting (at least two episodes of fainting with loss of consciousness or near loss of consciousness in the last year) of a vasovagal origin or associated with the postural orthostatic tachycardia syndrome (POTS) (as determined by a paediatric cardiologist) to take part in this study.Exclusion Criteria:Those with a diagnosis of recurrent fainting accompanied by any of the following will not be eligible to take part:Known history of:Suspected or confirmed cardiac arrhythmia (e.g., Wolff-Parkinson-White, Long QT)Traumatic head injuryNew presentation of a seizure disorder OR epilepsy recurrenceOverdose or intoxicationStructural heart diseaseCardiovascular disease including hypertension, diabetes, or renal diseaseHypoglycemiaPhysical and/or psychological disability that impact their ability to complete the testsFemale participants of childbearing age will be excluded if they are pregnant, or think they might be. Participants who are taking any cardiovascular acting medications, including treatment for cardiovascular disease, or medications for orthostatic syncope (e.g. fludrocortisone, slow-release sodium chloride, β-blockers, midodrine) will be excluded from the study.In order to reduce the likelihood of transmission of COVID-19, participants will only be eligible to participate in the study if they have received full immunisation against COVID-19 according to current Health Canada guidelines. Accordingly, participants will be asked to provide evidence of their vaccination status in order to take part in the study.

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Source: ClinicalTrials.gov (NCT05633693). StuddyBuddy aggregates publicly available trial information.