Recruiting

CPM

Sponsor:

Dr. Victoria Claydon

Code:

NCT05555771

Conditions

Syncope, Vasovagal

Postural Orthostatic Tachycardia Syndrome

Orthostatic Intolerance

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

Interventions

Counterpressure Maneuvers

Usual Care

Study Details

Brief 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

Study ID

NCT05555771

Start date

Sep 3, 2022

Status verified date

Apr, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Counterpressure Maneuvers

Participants will receive standard of care treatment (behavioural intervention and avoidance measures, as indicated in "Usual Care"), alongside training in counter pressure maneuvers. Training in counterpressure maneuvers will be delivered through a handout and video that will show three maneuvers (i.e. arm-tensing, squatting, and leg-crossing) that patients enrolled in the intervention arm can perform when they begin to experience common signs and symptoms of syncope. Patients will be instructed to start with one of the maneuvers and if their symptoms do not go away, move on to a second or third maneuver if needed.

active comparator: Usual Care

Participants will receive standard of care treatment for their diagnosis of syncope. This primarily includes behavioural interventions and avoidance measures (e.g., stay hydrated, increase salt intake, avoid hot situations, avoid standing for long periods of time, engage in regular physical activity). Some patients may be prescribed medication (Midodrine, Fludrocortisone) at the discretion of their physician.

Interventions

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.

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.

Primary outcome measure

  • Number of patients with syncopal recurrence [ Time Frame: One year, reported in monthly surveys. ]

Central Contacts and Locations

Central contacts

Erin L Williams, BSc

6048976372erin_williams_2@sfu.ca

Sonia Franciosi, PhD

(604) 875-2345Sonia.Franciosi@cw.bc.ca

Locations

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H3N1

Contacts

Sonia Franciosi, PhD

(604) 875-2345Sonia.Franciosi@cw.bc.ca

More Information

Sponsor

Dr. Victoria Claydon

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Victoria Claydon on 2026-04-23.