Paediatric Syncope in the Emergency Department

NCT05555771 | Recruiting

• 1 other identifier: H21-01749
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  One year, reported in monthly surveys.

Secondary Outcomes (4)

• Syncopal incidence

  One year

• Documentation of typical prodromal symptoms

  One year

• Number of patients with exercise-related syncope

  One year

• Number of patients with syncope secondary to other causes

  One year

Study Arms (2)

Counterpressure Maneuvers

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Physical counter maneuvers, counter maneuvers,

Counterpressure Maneuvers

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.

Usual Care

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients with hypoglycaemia and who are psychogenic with vasovagal syncope who do not present with prodromal symptoms
• Previously enrolled in this study

Sponsors & Collaborators

• Dr. Victoria Claydon: lead
• Provincial Health Services Authority British Columbia: collaborator
• University of British Columbia: collaborator
• Simon Fraser University: collaborator

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H3N1, Canada

RECRUITING

Related Publications (10)

• Primary Writing Committee; Sandhu RK, Raj SR, Thiruganasambandamoorthy V, Kaul P, Morillo CA, Krahn AD, Guzman JC, Sheldon RS; Secondary Writing Committee; Banijamali HS, MacIntyre C, Manlucu J, Seifer C, Sivilotti M. Canadian Cardiovascular Society Clinical Practice Update on the Assessment and Management of Syncope. Can J Cardiol. 2020 Aug;36(8):1167-1177. doi: 10.1016/j.cjca.2019.12.023. Epub 2020 Jul 2.

  PMID: 32624296 BACKGROUND

• Malloy-Walton L, Tisma-Dupanovic S. The approach to pediatric syncope with exercise. HeartRhythm Case Rep. 2019 Oct 15;5(10):485-488. doi: 10.1016/j.hrcr.2019.04.012. eCollection 2019 Oct. No abstract available.

  PMID: 33145167 BACKGROUND

• Sanatani S, Chau V, Fournier A, Dixon A, Blondin R, Sheldon RS. Canadian Cardiovascular Society and Canadian Pediatric Cardiology Association Position Statement on the Approach to Syncope in the Pediatric Patient. Can J Cardiol. 2017 Feb;33(2):189-198. doi: 10.1016/j.cjca.2016.09.006. Epub 2016 Oct 3.

  PMID: 27838109 BACKGROUND

• van Dijk N, Quartieri F, Blanc JJ, Garcia-Civera R, Brignole M, Moya A, Wieling W; PC-Trial Investigators. Effectiveness of physical counterpressure maneuvers in preventing vasovagal syncope: the Physical Counterpressure Manoeuvres Trial (PC-Trial). J Am Coll Cardiol. 2006 Oct 17;48(8):1652-7. doi: 10.1016/j.jacc.2006.06.059. Epub 2006 Sep 26.

  PMID: 17045903 BACKGROUND

• Runser LA, Gauer RL, Houser A. Syncope: Evaluation and Differential Diagnosis. Am Fam Physician. 2017 Mar 1;95(5):303-312.

  PMID: 28290647 BACKGROUND

• Chen L, Zhang Q, Ingrid S, Chen J, Qin J, Du J. Aetiologic and clinical characteristics of syncope in Chinese children. Acta Paediatr. 2007 Oct;96(10):1505-10. doi: 10.1111/j.1651-2227.2007.00446.x. Epub 2007 Aug 20.

  PMID: 17714543 BACKGROUND

• Anderson JB, Willis M, Lancaster H, Leonard K, Thomas C. The Evaluation and Management of Pediatric Syncope. Pediatr Neurol. 2016 Feb;55:6-13. doi: 10.1016/j.pediatrneurol.2015.10.018. Epub 2015 Nov 17.

  PMID: 26706050 BACKGROUND

• van Wijnen VK, Gans ROB, Wieling W, Ter Maaten JC, Harms MPM. Diagnostic accuracy of evaluation of suspected syncope in the emergency department: usual practice vs. ESC guidelines. BMC Emerg Med. 2020 Aug 3;20(1):59. doi: 10.1186/s12873-020-00344-9.

  PMID: 32746777 BACKGROUND

• Sheldon R, Rose S, Connolly S, Ritchie D, Koshman ML, Frenneaux M. Diagnostic criteria for vasovagal syncope based on a quantitative history. Eur Heart J. 2006 Feb;27(3):344-50. doi: 10.1093/eurheartj/ehi584. Epub 2005 Oct 13.

  PMID: 16223744 BACKGROUND

• Calkins H, Shyr Y, Frumin H, Schork A, Morady F. The value of the clinical history in the differentiation of syncope due to ventricular tachycardia, atrioventricular block, and neurocardiogenic syncope. Am J Med. 1995 Apr;98(4):365-73. doi: 10.1016/S0002-9343(99)80315-5.

  PMID: 7709949 BACKGROUND

Related Links

• Counterpressure maneuver training video - provided to all participants randomized to intervention arm

MeSH Terms

Conditions

Syncope, Vasovagal; Postural Orthostatic Tachycardia Syndrome; Orthostatic Intolerance

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shubhayan Sanatani, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin L Williams, BSc

CONTACT

6048976372; erin_williams_2@sfu.ca

Sonia Franciosi, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: September 3, 2022
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)