Canadian Prehospital Syncope Risk Score (Prehospital CSRS)

NCT05560126 | Not Yet Recruiting

• 1 other identifier: 4136
• Study Type: observational
• Target: 4,875
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Syncope is defined as a sudden, brief loss of consciousness (LOC) followed by a rapid complete recovery. It accounts for 160,000 emergency department (ED) visits each year in Canada. Despite this, few people are hospitalized (\~15%) and even fewer will die (\~1%). Two-thirds of patients with syncope arrive at the ED by calling 911. There are many causes of syncope. Identifying patients at low risk for bad outcomes would allow paramedics to safely determine which patients need care in the ED from those who can remain home. The research team recently developed the Canadian Prehospital Syncope Risk Score (CPSRS) which accurately identified patients at low risk for 30-day serious outcomes. Objective: The goal of this study is to validate the accuracy of the CPSRS in the prehospital setting or refine if needed to predict the risk of 30-day serious outcomes for patients with syncope. Methods: The research team will enroll patients with syncope from five paramedic services across Canada (British Columbia - Vancouver and Kelowna areas only, London-Middlesex, York Region, Frontenac, and Ottawa). The research team will exclude patients \<18 years old, LOC \>5 minutes, changes in mental status from baseline, alcohol or drug intoxication, or language barrier. Paramedics will fill out a study data collection form with the CPSRS items and additional data should the tool need refinement. The data will be entered into a secure database and will assess patient outcomes (death and potentially life-threatening medical conditions) at 30 days. The research team will examine model accuracy using standard prediction measures and look to improve model accuracy if needed. The research team expects to enroll 4875 patients over a 1-year recruitment period based on annual call volumes. Expected Outcomes: Once validated, the tool could reduce the number of patients transported to the hospital by identifying those at low risk. This would improve patient-oriented care, while at the same time saving valuable paramedic and ED resources.

Conditions

Syncope

Keywords

Syncope; Emergency Medicine Services; Prehospital; Risk-stratification; Emergency Department

Outcome Measures

Primary Outcomes (1)

• A serious adverse event (SAE) occurring within 30 days of the 911 call

  The definition of SAE is consistent with our previous syncope research studies including the CPSRS derivation and comprises of any one of the following: a) Death due to a cause of syncope or an unknown cause; b) Arrhythmia; c) Myocardial infarction; d) Identification of serious structural heart disease; e) Aortic dissection; f) Pulmonary embolism; g) Severe pulmonary artery hypertension; h) Subarachnoid hemorrhage; i) Significant hemorrhage; j) Other serious conditions such as ectopic pregnancy, pneumothorax, or sepsis that will require treatment, or any intervention used to treat a cause of syncope.

  30 days after the 911 call

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who access paramedic services through the 911 system will be included if they have suffered syncope, defined as a sudden transient loss of consciousness followed by spontaneous complete recovery.

You may qualify if:

• Patients who access paramedic services through the 911 system will be included if they have suffered syncope, defined as a sudden transient loss of consciousness followed by spontaneous complete recovery.

You may not qualify if:

• Pediatric patients (\<18 years old),
• Patients who have a prolonged period of unconsciousness (\>5 minutes),
• Change in mental status from baseline, witnessed seizure,
• Loss of consciousness due to head trauma (i.e., trauma was the initial event),
• or if unable to provide accurate details due to language barrier, cognitive impairment, alcohol, or drug intoxication.

Sponsors & Collaborators

• Venkatesh Thiruganasambandamoorthy: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Syncope; Emergencies

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Venkatesh Thiruganasambandamoorthy, CCFP-EM, MSc

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Nguyen, BSc

CONTACT

613-798-5555; pnguyen@ohri.ca

Jane Park, BHSc

CONTACT

613-798-5555; junpark@ohri.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 29, 2022
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)