Counterpressure Maneuvers for Fainting

(DETECT-ED Trial)

Overseen By Sonia Franciosi, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Victoria Claydon

Disqualifiers: Cardiac arrhythmia, Seizure disorder, Epilepsy, Overdose, Structural heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

300 Participants Needed

What You Need to Know Before You Apply

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.

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 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{8 10 11 12 13}

Who Is on the Research Team?

Shubhayan Sanatani, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Counterpressure Maneuvers Experimental Treatment 1 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 Care Active Control 1 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of surgical approaches for acetabular fractures with associated gluteal vascular injury. Tabor, OB., Bosse, MJ., Greene, KG., et al.[2019]

A new surgical procedure targeting the anterior fibers of the gluteus medius and minimus was developed to correct internal rotation gait without affecting hip abductor function.

In a study involving 12 hips, this procedure successfully improved gait in all cases while preserving hip abductor strength, suggesting a safer and more effective approach to treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Joseph, B.[2013]

A study involving 48 healthy college students found that training for gluteus medius strength (GMS) and proprioception improved dynamic postural control, as measured by the Star Excursion Balance Test (SEBT).

While no significant differences were found between the training groups, the combination of GMS and proprioception training led to the greatest improvements in balance, suggesting that a multifaceted approach may be beneficial for enhancing postural control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effects of 6-week balance, gluteus medius strength, and combined programs on dynamic postural control. Leavey, VJ., Sandrey, MA., Dahmer, G.[2019]

In a study of 18 patients, lower body skeletal muscle tensing (LBMT) significantly reduced the drop in mean arterial blood pressure (MAP) when standing up from a squatting position, helping to prevent presyncopal symptoms.

Using LBMT while standing up from squatting resulted in a higher MAP (76 mmHg) compared to standing without LBMT (64 mmHg), indicating that LBMT is an effective strategy to mitigate hemodynamic stress and prevent fainting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing squatting as a physical maneuver to prevent vasovagal syncope. Krediet, CT., Go-Schön, IK., van Lieshout, JJ., et al.[2022]

Physical counter pressure maneuvers (CPM) significantly improved standing blood pressure and heart rate, indicating their potential efficacy in preventing syncope, with a notable increase in systolic blood pressure by +14.8 mmHg and heart rate by +1.4 bpm.

Despite the positive effects of CPM in laboratory and community settings, practical limitations, such as the inability to recognize the onset of fainting, may hinder their everyday use, suggesting a need for further research on their application in real-world scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counter pressure maneuvers for syncope prevention: A semi-systematic review and meta-analysis. Williams, EL., Khan, FM., Claydon, VE.[2022]

In patients with recurrent vasovagal syncope, leg crossing significantly increases cardiac output (CO) by 9.5% and mean arterial pressure (BP) by 3.3%, suggesting it can be an effective preventive maneuver against fainting.

Adding muscle tensing to leg crossing further enhances CO by 8.3% and BP by 7.8%, with the response being more pronounced in older individuals, indicating that these physical maneuvers can be tailored for different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodynamic effects of leg crossing and skeletal muscle tensing during free standing in patients with vasovagal syncope. van Dijk, N., de Bruin, IG., Gisolf, J., et al.[2013]

In patients with a history of vasovagal syncope, various physical maneuvers like leg tensing and squatting significantly increased blood pressure (BP) and cardiac output (CO) within 3-5 seconds, indicating their potential effectiveness in aborting vasovagal reactions.

The study found that the increase in BP during these maneuvers was primarily due to an increase in cardiac output, rather than changes in total peripheral resistance, suggesting that enhancing heart function is key to preventing fainting episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leg crossing, muscle tensing, squatting, and the crash position are effective against vasovagal reactions solely through increases in cardiac output. Krediet, CT., de Bruin, IG., Ganzeboom, KS., et al.[2013]

The 'Anti-G-Suit' effectively treats postural hypotension during surgery, leading to a significant mean increase in systolic blood pressure of about 60% in hypotensive patients.

This external counterpressure garment enhances blood flow dynamics by increasing peripheral resistance and improving venous return, allowing surgeries to be safely performed on all hypotensive patients, even those in poor condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of the "anti-G-suit" during operations in the sitting position as a treatment of postural hypotension.(author's transl)]. Auer, L.[2019]

In a study involving 13 recreationally active females, both the prone bent-leg hip extension and the standing glute squeeze positions produced similar peak electromyography (EMG) readings for the gluteus maximus, indicating no significant difference in muscle activation between the two positions.

The results suggest that there is no single ideal position for testing gluteus maximus strength, and researchers should consider using multiple positions to improve accuracy in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two gluteus maximus EMG maximum voluntary isometric contraction positions. Contreras, B., Vigotsky, AD., Schoenfeld, BJ., et al.[2022]

A series of unique cases revealed that gluteal muscle contracture (GMC) is often associated with congenital heart disease (CHD) in children, suggesting a potential link between these conditions.

The study recommends reducing intramuscular injections in CHD patients, emphasizing the need for thorough cardiac examinations and advanced imaging techniques like 3D-CT to better understand GMC before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Congenital heart disease in adolescents with gluteal muscle contracture. You, T., Zhang, XT., Zha, ZG., et al.[2022]

The distal gluteus maximus-posterior thigh myofascial cutaneous flap is a reliable option for reconstructing large trochanteric pressure sores due to its dual blood supply from both the gluteal system and the deep femoral artery.

This flap offers versatility in design, allowing it to be based solely on the gluteal system's perforators or utilizing its dual circulation, providing advantages over other previously described surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The distal gluteus maximus advancement musculocutaneous flap for coverage of trochanteric pressure sores. Ramirez, OM.[2019]

Citations

1. Japan pubmed.ncbi.nlm.nih.gov

Effect of paralyzed side soleus muscle pressure on the gait of stroke patients as measured by a three-dimensional motion analysis system. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

The knee kinematic pattern associated with disruption of the knee extensor mechanism in ambulant patients with diplegic cerebral palsy. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of surgical approaches for acetabular fractures with associated gluteal vascular injury. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Comparative effects of 6-week balance, gluteus medius strength, and combined programs on dynamic postural control. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Optimizing squatting as a physical maneuver to prevent vasovagal syncope. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Counter pressure maneuvers for syncope prevention: A semi-systematic review and meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Hemodynamic effects of leg crossing and skeletal muscle tensing during free standing in patients with vasovagal syncope. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Leg crossing, muscle tensing, squatting, and the crash position are effective against vasovagal reactions solely through increases in cardiac output. [2013]

10. Austria pubmed.ncbi.nlm.nih.gov

[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 States pubmed.ncbi.nlm.nih.gov

A comparison of two gluteus maximus EMG maximum voluntary isometric contraction positions. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Congenital heart disease in adolescents with gluteal muscle contracture. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

The distal gluteus maximus advancement musculocutaneous flap for coverage of trochanteric pressure sores. [2019]