← Back to Search

N/A

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

Must not have

Epilepsy recurrence

Known history of traumatic head injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My epilepsy has come back.

Select...

I have had a traumatic head injury in the past.

Select...

I have a known history of heart disease.

Select...

I have a known heart rhythm problem.

Select...

I have recently started having seizures.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Syncope

Secondary study objectives

Documentation of typical prodromal symptoms

Number of patients with exercise-related syncope

Number of patients with syncope secondary to other causes

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met