Counterpressure Maneuvers for Fainting (DETECT-ED Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByShubhayan Sanatani, MD
Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dr. Victoria Claydon
No Placebo Group
Trial Summary
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.
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.
348911Do 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.
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.
2341012What 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.
156713Eligibility 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 am between 6 and 18 years old.
Exclusion Criteria
My epilepsy has come back.
I have had a traumatic head injury in the past.
I have a known history of heart disease.
I have a known heart rhythm problem.
I have recently started having seizures.
Participant Groups
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.
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
Research locations nearbySelect from list below to view details:
BC Children's HospitalVancouver, Canada
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Who is running the clinical trial?
Dr. Victoria ClaydonLead Sponsor
University of British ColumbiaCollaborator
Simon Fraser UniversityCollaborator
Provincial Health Services AuthorityCollaborator
References
[The use of the "anti-G-suit" during operations in the sitting position as a treatment of postural hypotension.(author's transl)]. [2019]The use of the "Anti-G-Suit" in patients with postural hypotension is described. Acute falls in the blood pressure during operations in the sitting position can be successfully treated with the aid of an external counterpressure garment reaching from ankles to xiphoid process. The mean increase in systolic blood pressure was about 60% in hypotensive and 17% in normotensive control patients. A reciprocal relation between pre-treatment blood pressure and its increase after use of the "G-Suit" was noticed. In contrast to previous practice, we were able to operate on all hypotensive patients in poor condition. The effect of external counterpressure on the lower part of the body can be explained by increase of peripheral resistance and decrease of vascular flow, resulting in better venous return, displacement of the circulating blood above the diaphragm and augmentation of systolic blood pressure.
The distal gluteus maximus advancement musculocutaneous flap for coverage of trochanteric pressure sores. [2019]Large trochanteric pressure sores can be reconstructed with the superolateral advancement of the distal gluteus maximus-posterior thigh myofascial cutaneous flap. The flap has a dual blood supply derived from the gluteal system and the deep femoral artery. This makes the distal gluteus maximus advancement flap very reliable and versatile. It can be designed on the musculocutaneous perforators of the gluteal system alone or on its dual circulation. It has several advantages over previously described flaps for trochanteric pressure sores.
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]Spastic overactivity of the anterior fibers of the gluteus medius and minimus can result in an internal rotation gait associated with excessive hip and pelvic rotation. The currently advocated operation for this problem can result in weakness of hip abduction. The anatomical features of the gluteal muscles suggest that this gait abnormality can be corrected by selectively reducing the internal rotator function of the anterior fibers of the glutei without disturbing the abductor fibers. Such an operative procedure was devised and performed on 12 hips. The gait improved in all hips without any demonstrable weakness of the hip abductor power.
Effects of surgical approaches for acetabular fractures with associated gluteal vascular injury. [2019]To examine the viability of the abductor muscles following extensile exposures to the acetabulum in the presence of superior gluteal artery (SGA) or vein (SGV) injury.
Hemodynamic effects of leg crossing and skeletal muscle tensing during free standing in patients with vasovagal syncope. [2013]Physical maneuvers can be applied to abort or delay an impending vasovagal faint. These countermaneuvers would be more beneficial if applied as a preventive measure. We hypothesized that, in patients with recurrent vasovagal syncope, leg crossing produces a rise in cardiac output (CO) and thereby in blood pressure (BP) with an additional rise in BP by muscle tensing. We analyzed the age and gender effect on the BP response. To confirm that, during the maneuvers, Modelflow CO changes in proportion to actual CO, 10 healthy subjects performed the study protocol with CO evaluated simultaneously by Modelflow and by inert gas rebreathing. Changes in Modelflow CO were similar in direction and magnitude to inert gas rebreathing-determined CO changes. Eighty-eight patients diagnosed with vasovagal syncope applied leg crossing after a 5-min free-standing period. Fifty-four of these patients also applied tensing of leg and abdominal muscles. Leg crossing produced a significant rise in CO (+9.5%; P
Leg crossing, muscle tensing, squatting, and the crash position are effective against vasovagal reactions solely through increases in cardiac output. [2013]Tensing of lower body muscles without or with leg crossing (LBMT, LCMT), whole body tensing (WBT), squatting, and sitting with the head bent between the knees ("crash position", HBK) are believed to abort vasovagal reactions. The underlying mechanisms are unknown. To study these interventions in patients with a clinical history of vasovagal syncope and a vasovagal reaction during routine tilt table testing, we measured blood pressure (BP) continuously with Finapres and derived heart rate, stroke volume, cardiac output (CO), and total peripheral resistance using Modelflow. In series A (n = 12) we compared LBMT to LCMT. In series B (n = 9), WBT was compared with LCMT. In series C (n = 14) and D (n = 9), we tested squatting and HBK. All maneuvers caused an increase in BP, varying from a systolic rise from 77 +/- 8 to 104 +/- 18 mmHg (P
Optimizing squatting as a physical maneuver to prevent vasovagal syncope. [2022]Squatting is a potent physical maneuver to prevent syncope; however, a major drawback is that standing up from squatting is a large hemodynamic stressor that often causes new presyncopal symptoms. We tested the hypothesis that lower body skeletal muscle tensing (LBMT) attenuates the decrease of mean arterial blood pressure (MAP) upon standing from squatting when used as a maneuver to prevent vasovagal syncope.
The knee kinematic pattern associated with disruption of the knee extensor mechanism in ambulant patients with diplegic cerebral palsy. [2013]Failure of the knee extensor mechanism is a potentially disastrous complication of diplegic cerebral palsy and if left undiagnosed may lead to a cessation of independent walking. The disruption of the extensor mechanism usually occurs through or distal to the patella. The aim of this article is to describe the knee kinematic pattern associated with such knee pathology. We also present a mathematical model of knee crouch that leads to this problem. In a retrospective review of patients with radiographically proven disruption, we compared the postfailure clinical and kinematic data to premorbid data. All patients included in this study had attended our clinical Gait Analysis Laboratory on two occasions. In the patients with disruption of the extensor mechanism, the kinematic pattern changed from crouch with shock absorption to one of increased crouch and loss of shock absorption. Clinical characteristics included knee flexion contracture and increased hamstring tightness. We demonstrate how the prefailure crouch position of the knee increases the flexor moment arm about the knee. We suggest that this knee crouch position during walking is the primary cause of pathology. Failure of the knee extensor mechanism is associated with a distinctive knee kinematic pattern. Regular gait analysis can help identify this pathology and enable treatment to be planned accordingly.
Comparative effects of 6-week balance, gluteus medius strength, and combined programs on dynamic postural control. [2019]There are few outcomes-based studies that address hip strategy and gluteus medius strength (GMS) for maintaining dynamic postural control.
Congenital heart disease in adolescents with gluteal muscle contracture. [2022]Gluteal muscle contracture (GMC), presented with hip abduction and external rotation when crouching, is common in several ethnicities, particularly in Chinese. It remains unclear that the reasons why these children are weak and have no choice to accept repeated intramuscular injection. Here, we found some unique cases which may be useful to explain this question. We describe a series of special GMC patients, who are accompanied with congenital heart disease (CHD). These cases were first observed in preoperative examinations of a patient with atrial septal defect (ASD), which was proved by chest X-ray and cardiac ultrasound. From then on, we gradually identified additional 3 GMC patients with CHD. The original patient with ASD was sent to cardiosurgery department to repair atrial septal first and received arthroscopic surgery later. While the other 3 were cured postoperative of ventricular septal defect (VSD), tetralogy of fallot (TOF), patent ductus arteriosus (PDA), respectively, and had surgery directly. The study gives us 3 proposals: (1) as to CHD children, it is essential to decrease the use of intramuscular injection, (2) paying more attention to cardiac examination especially cardiac ultrasound in perioperative period, and (3) taking 3D-CT to reconstruct gluteal muscles for observing contracture bands clearly in preoperation. However, more larger series of patients are called for to confirm these findings.
Effect of paralyzed side soleus muscle pressure on the gait of stroke patients as measured by a three-dimensional motion analysis system. [2020][Purpose] The purpose of this study was to examine the effects of muscle belly compression by a supporter on the paralyzed side soleus muscle of patients with cerebrovascular disability, and to determine the intensity of compression that is effective for improving gait. [Subjects] Eleven patients with chronic cerebral vascular disorder. [Methods] Before setting the supporter, standing posture and 6 m free walking were measured 3 times with the three-dimensional motion analysis system, VICON. Then, supporters were placed on the center of the lower leg of the hemiplegic side of the subjects and inflated to 30 or 50 mmHg. Three minutes after wearing the supporters, the subjects walked again for 3 times. The data measured with VICON were processed using Visial3D.V4, and the angles of the ankle, steps of the hemiplegic and non-hemiplegic sides, walking speed, walk rate and cadence were calculated. [Results] Compared to without a supporter, a supporter with 30 mmHg pressure showed a significant reduction in the angle of the knee at Initial Contact (IC), and a significant increase in the power of the knee extension at Loading Response (LR). [Conclusion] The results reveal a supporter with that of the subjects during pressure over 30 mmHg applied for 3 minutes improved the knee angle power and hemiplegia walking.
A comparison of two gluteus maximus EMG maximum voluntary isometric contraction positions. [2022]Background. The purpose of this study was to compare the peak electromyography (EMG) of the most commonly-used position in the literature, the prone bent-leg (90°) hip extension against manual resistance applied to the distal thigh (PRONE), to a novel position, the standing glute squeeze (SQUEEZE). Methods. Surface EMG electrodes were placed on the upper and lower gluteus maximus of thirteen recreationally active females (age = 28.9 years; height = 164 cm; body mass = 58.2 kg), before three maximum voluntary isometric contraction (MVIC) trials for each position were obtained in a randomized, counterbalanced fashion. Results. No statistically significant (p
Counter pressure maneuvers for syncope prevention: A semi-systematic review and meta-analysis. [2022]Physical counter pressure maneuvers (CPM) are movements that are recommended to delay or prevent syncope (fainting) by recruiting the skeletal muscle pump to augment cardiovascular control. However, these recommendations are largely based on theoretical benefit, with limited data evaluating the efficacy of CPM to prevent syncope in the real-world setting. We conducted a semi-systematic literature review and meta-analysis to assess CPM efficacy, identify literature gaps, and highlight future research needs. Articles were identified through a literature search (PubMed, April 2022) of peer-reviewed publications evaluating the use of counter pressure or other lower body maneuvers to prevent syncope. Two team members independently screened records for inclusion and extracted data. From 476 unique records identified by the search, 45 met inclusion criteria. Articles considered various syncopal conditions (vasovagal = 12, orthostatic hypotension = 8, postural orthostatic tachycardia syndrome = 1, familial dysautonomia = 2, spinal cord injury = 1, blood donation = 10, healthy controls = 11). Maneuvers assessed included hand gripping, leg fidgeting, stepping, tiptoeing, marching, calf raises, postural sway, tensing (upper, lower, whole body), leg crossing, squatting, "crash" position, and bending foreword. CPM were assessed in laboratory-based studies (N = 28), the community setting (N = 4), both laboratory and community settings (N = 3), and during blood donation (N = 10). CPM improved standing systolic blood pressure (+ 14.8 ± 0.6 mmHg, p < 0.001) and heart rate (+ 1.4 ± 0.5 bpm, p = 0.006), however, responses of total peripheral resistance, stroke volume, or cerebral blood flow were not widely documented. Most patients experienced symptom improvement following CPM use (laboratory: 60 ± 4%, community: 72 ± 9%). The most prominent barrier to employing CPM in daily living was the inability to recognize an impending faint. Patterns of postural sway may also recruit the skeletal muscle pump to enhance cardiovascular control, and its potential as a discrete, proactive CPM needs further evaluation. Physical CPM were successful in improving syncopal symptoms and producing cardiovascular responses that may bolster against syncope; however, practical limitations may restrict applicability for use in daily living.