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Counterpressure Maneuvers for Fainting (DETECT-ED Trial)

N/A

Recruiting

Led By Shubhayan Sanatani, MD

Research Sponsored by Dr. Victoria Claydon

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

DETECT-ED Trial Summary

This trial will assess whether counterpressure maneuvers (CPM) can prevent syncope in children. In stage I, participants will fill out a survey about their syncopal episode and any prodromal symptoms. In stage II, some participants will be trained in CPM and all will be followed for one year. Surveys and medical records will be used to assess syncopal and presyncopal recurrence and changes in medical diagnosis.

Who is the study for?

This trial is for kids aged 6-18 who've fainted recently and show up at the emergency room between 10 am and 10 pm. They should be able to understand English to fill out surveys. Kids with heart rhythm problems, head injuries, seizures, drug overdoses, or certain fainting conditions without warning signs can't join.Check my eligibility

What is being tested?

The study tests if special body-tightening exercises (like crossing legs) help stop fainting in kids when added to normal care they get in the ER. Half will just get regular care; the other half will learn these exercises too. Everyone's followed for a year with monthly check-ins on their fainting spells.See study design

What are the potential side effects?

There are no direct side effects from learning counterpressure maneuvers since they're simple physical actions like leg crossing or arm tensing. Usual care in the ER doesn't change except for adding these exercises.

DETECT-ED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 6 and 18 years old.

DETECT-ED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Syncope

Secondary outcome measures

Documentation of typical prodromal symptoms

Number of patients with exercise-related syncope

Number of patients with syncope secondary to other causes

+1 more

DETECT-ED Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Counterpressure ManeuversExperimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of British ColumbiaOTHER

1,415 Previous Clinical Trials

2,466,716 Total Patients Enrolled

Dr. Victoria ClaydonLead Sponsor

Simon Fraser UniversityOTHER

52 Previous Clinical Trials

9,298 Total Patients Enrolled

1 Trials studying Vasovagal Syncope

25 Patients Enrolled for Vasovagal Syncope

Media Library

Counterpressure Maneuvers (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT05555771 — N/A

Vasovagal Syncope Research Study Groups: Usual Care, Counterpressure Maneuvers

Vasovagal Syncope Clinical Trial 2023: Counterpressure Maneuvers Highlights & Side Effects. Trial Name: NCT05555771 — N/A

Counterpressure Maneuvers (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05555771 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment accommodate geriatric individuals?

"This clinical trial is inviting individuals between the age of 6 and 18 to participate."

Answered by AI

Is recruitment for this medical research still open?

"Affirmative. It is discernible from the information on clinicaltrials.gov that this medical trial, which was originally advertised on September 3rd 2022, is actively recruiting individuals to participate in it. A total of 300 participants need to be admitted across 1 healthcare centre."

Answered by AI

What does the research team hope to accomplish through this investigation?

"This study aims to evaluate the number of patients with syncopal recurrence over a 12 month period. Secondary objectives are to define predictive factors for syncope secondary to other causes, determine diagnosis in pediatric patients who may experience exercise-related syncope, and document typical prodromal symptoms that link different types of syncope in the pediatric population after 1 year follow up."

Answered by AI

Who has the requisite qualifications to join this medical study?

"Candidates that would like to take part in this medical trial must possess syncope, be younger than 18 years old and older than 6 years. The maximum amount of participants allowed is 300 individuals."

Answered by AI

How many participants have been recruited for this experiment?

"Affirmative. As per the data posted on clinicaltrials.gov, this trial currently requires participants and was first listed on September 3rd 2022. The most recent changes were made November 10th 2022 and 300 people are needed from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Paediatric Syncope in the Emergency Department

Dr. Victoria Claydon 2022. "Paediatric Syncope in the Emergency Department". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05555771.

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