Assessing counterpressure maneuvers for preventing fainting in children
Determining the Effectiveness of Counterpressure Maneuvers in Pediatric Patients Presenting With Syncope to the Emergency Department
This study is testing if teaching children techniques to prevent fainting can help them avoid losing consciousness when they visit the emergency room.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Simon Fraser University Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05555771 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of counterpressure maneuvers (CPM) in preventing syncope among pediatric patients who present to the emergency department with transient loss of consciousness. Participants aged 6-18 will first complete a survey about their syncopal episodes and then be randomly assigned to either receive usual care or training in CPM techniques alongside usual care. The study will follow participants for one year, collecting monthly surveys on their syncopal and presyncopal occurrences, while also reviewing medical records for any changes in diagnosis. The goal is to better understand pediatric syncope and improve management strategies.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 6-18 who have experienced a transient loss of consciousness within the past week.
Not a fit: Patients with known cardiac arrhythmias, traumatic head injuries, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective techniques for preventing fainting episodes in children, improving their quality of life and safety.
How similar studies have performed: While research on pediatric syncope is limited, studies in adults have shown that counterpressure maneuvers can be effective, suggesting potential for success in this pediatric population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Those between the ages of 6-18 years (inclusive) 2. Presenting to the ED daily 1000-2200 with resolved transient loss of consciousness that has occurred within the last week 3. Able to complete the survey in English 4. Willing and able to provide consent and assent Exclusion Criteria: 1. Those with a known history of any of the following: * Suspected or confirmed cardiac arrhythmia diagnosis (e.g., Wolff-Parkinson-White, long QT) * Traumatic head injury * New presentation of seizure disorder * Epilepsy recurrence * Overdose, intoxication * Structural heart disease 2. Patients with hypoglycaemia and who are psychogenic with vasovagal syncope who do not present with prodromal symptoms 3. Previously enrolled in this study
Where this trial is running
Vancouver, British Columbia
- BC Children's Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Shubhayan Sanatani, MD — University of British Columbia
- 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.