300 Participants Needed

Counterpressure Maneuvers for Fainting

(DETECT-ED Trial)

EL
SF
Overseen BySonia Franciosi, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but you should confirm with the study team.

What data supports the idea that Counterpressure Maneuvers for Fainting is an effective treatment?

The available research does not provide any data specifically supporting the effectiveness of Counterpressure Maneuvers for Fainting. The studies mentioned focus on different conditions and treatments, such as gait improvement in stroke patients and surgical approaches for cerebral palsy, but do not address Counterpressure Maneuvers for Fainting.12345

What safety data exists for counterpressure maneuvers for fainting?

The safety data for counterpressure maneuvers (CPM) for fainting is limited but suggests potential benefits. Studies show that CPM can improve cardiovascular responses, such as increasing blood pressure and heart rate, which may help prevent syncope. However, practical limitations, like recognizing an impending faint, may restrict their daily use. Specific maneuvers like leg crossing, muscle tensing, and squatting have been shown to increase cardiac output and blood pressure, potentially preventing vasovagal syncope. The use of external counterpressure garments, like the 'Anti-G-Suit,' has also been effective in treating postural hypotension by increasing peripheral resistance and venous return. Overall, while CPMs show promise, more research is needed to fully understand their safety and efficacy in real-world settings.678910

Is the treatment Counterpressure Maneuvers for fainting promising?

The treatment Counterpressure Maneuvers, which includes techniques like leg crossing and muscle tensing, is promising because it can help prevent fainting by improving blood flow and maintaining blood pressure.34111213

What is the purpose of this trial?

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.

Research Team

SS

Shubhayan Sanatani, MD

Principal Investigator

University of British Columbia

Eligibility Criteria

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.

Inclusion Criteria

I fainted within the last week but now feel normal.
I am between 6 and 18 years old.
Willing and able to provide consent and assent
See 1 more

Exclusion Criteria

My epilepsy has come back.
You have recently taken too much of a substance or have been intoxicated.
I have fainting spells without warning due to low blood sugar and psychological factors.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Stage I: Presentation of Syncope

Participants complete a survey documenting their syncopal episode and prodromal symptoms

1 week
1 visit (in-person)

Stage II: Treatment

Participants receive either usual care or training in counterpressure maneuvers alongside usual care

1 year
Monthly surveys (virtual)

Follow-up

Participants are monitored for syncopal recurrence and other outcomes

1 year
Monthly surveys (virtual)

Treatment Details

Interventions

  • Counterpressure Maneuvers
  • Usual Care
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dr. Victoria Claydon

Lead Sponsor

Trials
1
Recruited
300+

University of British Columbia

Collaborator

Trials
1,506
Recruited
2,528,000+

Simon Fraser University

Collaborator

Trials
59
Recruited
12,500+

Provincial Health Services Authority

Collaborator

Trials
40
Recruited
31,900+

Findings from Research

In a study involving 11 patients with chronic cerebrovascular disorders, using a muscle belly supporter inflated to 30 mmHg significantly improved knee extension power during walking, indicating potential benefits for gait rehabilitation.
The application of 30 mmHg pressure for just 3 minutes led to a notable reduction in knee angle at initial contact, suggesting that targeted compression can enhance walking mechanics in individuals with hemiplegia.
Effect of paralyzed side soleus muscle pressure on the gait of stroke patients as measured by a three-dimensional motion analysis system.Miura, N., Katsuhira, J., Kurosawa, K.[2020]
In patients with diplegic cerebral palsy, failure of the knee extensor mechanism is linked to a specific kinematic pattern characterized by increased crouch and loss of shock absorption, which can lead to the cessation of independent walking.
Regular gait analysis is crucial for identifying this knee pathology early, allowing for timely intervention and treatment planning to prevent further complications.
The knee kinematic pattern associated with disruption of the knee extensor mechanism in ambulant patients with diplegic cerebral palsy.O'Sullivan, R., Walsh, M., Kiernan, D., et al.[2013]
In a study involving 22 dogs, ligation of the superior gluteal artery (SGA) during extensive surgical exposure to the acetabulum resulted in significant reductions in blood flow and muscle mass of the abductor muscles, indicating potential risks associated with this surgical approach.
However, the study found that complete muscle necrosis did not occur, and dogs undergoing a two-incision approach with SGA ligation showed minimal changes in muscle mass and perfusion, suggesting that this technique may preserve abductor muscle viability better than previously thought.
Effects of surgical approaches for acetabular fractures with associated gluteal vascular injury.Tabor, OB., Bosse, MJ., Greene, KG., et al.[2019]

References

Effect of paralyzed side soleus muscle pressure on the gait of stroke patients as measured by a three-dimensional motion analysis system. [2020]
The knee kinematic pattern associated with disruption of the knee extensor mechanism in ambulant patients with diplegic cerebral palsy. [2013]
Effects of surgical approaches for acetabular fractures with associated gluteal vascular injury. [2019]
Treatment of internal rotation gait due to gluteus medius and minimus overactivity in cerebral palsy: anatomical rationale of a new surgical procedure and preliminary results in twelve hips. [2013]
Comparative effects of 6-week balance, gluteus medius strength, and combined programs on dynamic postural control. [2019]
Optimizing squatting as a physical maneuver to prevent vasovagal syncope. [2022]
Counter pressure maneuvers for syncope prevention: A semi-systematic review and meta-analysis. [2022]
Hemodynamic effects of leg crossing and skeletal muscle tensing during free standing in patients with vasovagal syncope. [2013]
Leg crossing, muscle tensing, squatting, and the crash position are effective against vasovagal reactions solely through increases in cardiac output. [2013]
[The use of the "anti-G-suit" during operations in the sitting position as a treatment of postural hypotension.(author's transl)]. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
A comparison of two gluteus maximus EMG maximum voluntary isometric contraction positions. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Congenital heart disease in adolescents with gluteal muscle contracture. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
The distal gluteus maximus advancement musculocutaneous flap for coverage of trochanteric pressure sores. [2019]
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