Postural Orthostatic Tachycardia Syndrome Clinical Trial
— DETECT-EDOfficial title:
Determining the Effectiveness of Counterpressure Maneuvers in Pediatric Patients Presenting With Syncope to the Emergency Department
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | BC Children's Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Dr. Victoria Claydon | Provincial Health Services Authority, Simon Fraser University, University of British Columbia |
Canada,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Runser LA, Gauer RL, Houser A. Syncope: Evaluation and Differential Diagnosis. Am Fam Physician. 2017 Mar 1;95(5):303-312. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Syncopal incidence | Report on the incidence of syncope in our cohort | One year | |
Secondary | 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. | One year | |
Secondary | Number of patients with exercise-related syncope | Determine the diagnosis of pediatric patients who may experience syncope that is temporally associated to exercise | One year | |
Secondary | Number of patients with syncope secondary to other causes | Report on predictive factors for syncope secondary to other causes | One year |
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