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Paediatric Syncope in the Emergency Department

ConditionsSyncope, VasovagalPostural Orthostatic Tachycardia SyndromeOrthostatic Intolerance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorDr. Victoria Claydon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Those between the ages of 6-18 years (inclusive)

Presenting to the ED daily 1000-2200 with resolved transient loss of consciousness that has occurred within the last week

Able to complete the survey in English

Willing and able to provide consent and assent

Disqualifiers

Suspected or confirmed cardiac arrhythmia diagnosis (e.g., Wolff-Parkinson-White, long QT)

Traumatic head injury

New presentation of seizure disorder

Epilepsy recurrence

Trial design

Design model

Parallel

Treatments tested in this trial

  • Counterpressure Maneuvers

    Behavioral

    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

    Behavioral

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Counterpressure ManeuversExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with syncopal recurrence

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.

Time frame
One year, reported in monthly surveys.

Secondary outcomes

1

Syncopal incidence

Report on the incidence of syncope in our cohort

Time frame
One year
2

Documentation of typical prodromal symptoms

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.

Time frame
One year
3

Number of patients with exercise-related syncope

Determine the diagnosis of pediatric patients who may experience syncope that is temporally associated to exercise

Time frame
One year
4

Number of patients with syncope secondary to other causes

Report on predictive factors for syncope secondary to other causes

Time frame
One year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Victoria Claydon

Lead sponsor

Simon Fraser University

Sponsor institution

Provincial Health Services Authority British Columbia

Collaborator

University of British Columbia

Collaborator

Simon Fraser University

Collaborator

Source ClinicalTrials.gov
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