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Paediatric Syncope in the Emergency Department (DETECT-ED)

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ClinicalTrials.gov Identifier: NCT05555771
Recruitment Status : Recruiting
First Posted : September 27, 2022
Last Update Posted : November 15, 2022
Provincial Health Services Authority
University of British Columbia
Simon Fraser University
Information provided by (Responsible Party):
Dr. Victoria Claydon, Simon Fraser University

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.

Condition or disease Intervention/treatment Phase
Syncope, Vasovagal Postural Orthostatic Tachycardia Syndrome Orthostatic Intolerance Behavioral: Counterpressure Maneuvers Behavioral: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Determining the Effectiveness of Counterpressure Maneuvers in Pediatric Patients Presenting With Syncope to the Emergency Department
Actual Study Start Date : September 3, 2022
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arm Intervention/treatment
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.
Behavioral: 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.
Other Name: Physical counter maneuvers, counter maneuvers,

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.
Behavioral: 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 Measures :
  1. Number of patients with syncopal recurrence [ Time Frame: One year, reported in monthly surveys. ]
    Participant experiences an episode of syncope (transient loss of consciousness and postural tone followed by a spontaneous recovery) over the course of the one year follow up.

Secondary Outcome Measures :
  1. Syncopal incidence [ Time Frame: One year ]
    Report on the incidence of syncope in our cohort

  2. Documentation of typical prodromal symptoms [ Time Frame: One year ]
    Link the prodromal symptoms of the different types of syncope in the pediatric population with the final diagnosis after at least one year of follow-up.

  3. Number of patients with exercise-related syncope [ Time Frame: One year ]
    Determine the diagnosis of pediatric patients who may experience syncope that is temporally associated to exercise

  4. Number of patients with syncope secondary to other causes [ Time Frame: One year ]
    Report on predictive factors for syncope secondary to other causes

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05555771

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Contact: Erin L Williams, BSc 6048976372 erin_williams_2@sfu.ca
Contact: Sonia Franciosi, PhD (604) 875-2345 ext 7955 Sonia.Franciosi@cw.bc.ca

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Canada, British Columbia
BC Children's Hospital Recruiting
Vancouver, British Columbia, Canada, V6H3N1
Contact: Sonia Franciosi, PhD    (604) 875-2345 ext 7955    Sonia.Franciosi@cw.bc.ca   
Sponsors and Collaborators
Dr. Victoria Claydon
Provincial Health Services Authority
University of British Columbia
Simon Fraser University
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Principal Investigator: Shubhayan Sanatani, MD University of British Columbia
Additional Information:

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Responsible Party: Dr. Victoria Claydon, Professor, Simon Fraser University
ClinicalTrials.gov Identifier: NCT05555771    
Other Study ID Numbers: H21-01749
First Posted: September 27, 2022    Key Record Dates
Last Update Posted: November 15, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Orthostatic Intolerance
Postural Orthostatic Tachycardia Syndrome
Syncope, Vasovagal
Disease Attributes
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases