Improving blood pressure control in children who faint
Impact of Postural Sway on Cardiovascular Control in Pediatric Patients With Syncope
This study is testing if certain movements can help children aged 6-18 who faint feel better by improving their blood pressure and heart function compared to regular advice.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Simon Fraser University Academic / other |
| Locations | 1 site (Burnaby, British Columbia) |
| Trial ID | NCT05633693 on ClinicalTrials.gov |
What this trial studies
This investigation aims to evaluate the effectiveness of specific counterpressure maneuvers, such as exaggerated sway and gluteal muscle clenching, in enhancing blood pressure and cardiovascular control in pediatric patients experiencing recurrent fainting episodes. The study will involve 35 participants aged 6-18 years, who will undergo a series of tests to measure cardiovascular responses to these maneuvers compared to standard recommendations. Data collected will include blood pressure, cerebral blood flow, and stroke volume, alongside participant demographics and medical history. The goal is to determine if these new maneuvers provide a significant improvement over traditional methods.
Who should consider this trial
Good fit: Ideal candidates are English-speaking pediatric patients aged 6-18 years with a diagnosis of recurrent fainting of vasovagal origin or associated with postural orthostatic tachycardia syndrome.
Not a fit: Patients with known cardiovascular diseases, structural heart issues, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective management strategies for children suffering from recurrent fainting episodes.
How similar studies have performed: While the approach of using counterpressure maneuvers is established, this specific investigation is novel in its focus on pediatric patients and the particular maneuvers being tested.
Eligibility criteria
Show full inclusion / exclusion 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 injury * New presentation of a seizure disorder OR epilepsy recurrence * Overdose or intoxication * Structural heart disease * Cardiovascular disease including hypertension, diabetes, or renal disease * Hypoglycemia * Physical and/or psychological disability that impact their ability to complete the tests Female 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.
Where this trial is running
Burnaby, British Columbia
- Simon Fraser University — Burnaby, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Victoria E Claydon, PhD — Simon Fraser University
- Study coordinator: Erin L Williams, BSc
- Email: erin_williams_2@sfu.ca
- Phone: 6048976372
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.