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Compartment Syndromes clinical trials

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NCT ID: NCT06291389 Recruiting - Clinical trials for Abdominal Compartment Syndrome

Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication

Start date: March 10, 2024
Phase:
Study type: Observational

An abdominal panniculus excision procedure is known as an abdominoplasty (panniculectomy). Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This study aimed to evaluate the effect of intraoperative changes in peak airway pressure (PAP) after muscle plication on postoperative pulmonary function.

NCT ID: NCT06050499 Recruiting - Limb Ischemia Clinical Trials

Chemical Analysis of Limb Microfluidics

CALM
Start date: February 1, 2023
Phase:
Study type: Observational

Compartment syndrome (CS) is a condition where an increase in pressure in an anatomical compartment (e.g. the lower leg) affects the blood supply of the tissues, leading to tissue damage. The condition is difficult to diagnose, and more difficult to determine when and how to manage it. Treatment aims to reduce the pressure in the compartment by whatever means possible. Surgical management by of CS is highly invasive and has associated risks including infection, damage to local structures (i.e. nerves), and possibly the inability to close the wound leading to the need for further reconstructive procedures. The clinical challenge in suspected CS is knowing if and when to intervene. Some cases of mild CS may resolve without an operation, and therefore intervening too soon causes unnecessary harm to the patient. However, waiting too long to operate with high compartmental pressures may lead to irreversible damage to the tissues, resulting in either a useless limb or necrotic tissue needing amputation. Current strategies for determining limb health include interrogation of symptoms, signs on examination, and serial measurements of compartmental pressures, but no absolute measurement of tissue health. As such, there is an element of clinical judgment in management and no evidence base with which to develop clear treatment guidelines. There is a need for a minimally invasive method of continuously monitoring tissue health to improve the understanding of CS and its management before significant improvement in patient outcomes can be delivered. It is proposed the application of leg "microfluidics" - analysis of samples of leg fluid - in a series of predictable clinical scenarios which simulate the threatened and unsalvageable limb. This is with an ultimate aim of developing a method of limb fluid sampling that can predict if CS is present and requires intervention.

NCT ID: NCT06030635 Recruiting - Clinical trials for Compartment Syndromes

ACS Monitoring Charité Berlin

Start date: October 25, 2023
Phase: N/A
Study type: Interventional

Compartment syndrome is a very serious musculoskeletal disorder, which can lead to devastating consequences, such as limb amputation and life-threatening conditions. It is a well described medical condition considered to be an orthopaedic emergency affecting all ages. In the diagnosis of acute compartment syndrome, clinical suspicion supplemented by careful, repeated clinical examination continues to be the clinician's greatest tool. The classic signs and symptoms of acute compartment pressure are often listed as the 5 or 6 "Ps": Pain, Pressure, Pulselessness, Paralysis, Paresthesia, and Pallor. The diagnosis is typically not made by using equipment and it is difficult in the awake and oriented patient, becoming even more problematic in the polytrauma patient. An alternative diagnostic method for compartment syndrome is invasive intra-compartmental pressure measurement via insertion of a pressure monitoring device into the muscle compartment. However, literature shows that commercially available intra compartmental pressure monitors have a highly variable intra-observer reproducibility and that user errors are common. Compared to the invasive modalities or just experience of the surgeon, the CPMX1 shows promising advantages for the clinical application. Not only is the technology used for the CPMX1 device safe and non-invasive for the patient with only initial training required for the healthcare professionals, but it has also demonstrated high intra- and inter-observer reproducibility (as per bench tests and confirmed in clinical setting). Recently, two clinical studies ("SWISS_EVIDENCE" and "SWISS_CLEARANCE") were conducted using the CPMX1 in healthy volunteers in a real-world clinical environment. Results of these studies confirmed that the application of the CMPX1 in patient care is safe and validated the reliability of compressibility ratio measurement with the CPMX1 in healthy volunteers. The use of the CPMX1 device therefore facilitates the measurements, as it is based on pre- existing ultrasound methods, and avoids any further risks to the patients compared to invasive compartmental pressure diagnosis methods.

NCT ID: NCT05971264 Recruiting - Clinical trials for Abdominal Compartment Syndrome

Comparison of Bladder Pressure Versus Regional Intestinal Tissue Oxygenation in Infants

BPvsNIRS
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn more about intestinal regional oxygen saturation measurements made with near-infrared spectroscopy and bladder pressure measurements in infants without risk of intraabdominal hypertension. The main question it aims to answer is if - in comparison to bladder pressure - the regional intestinal oxygen saturation measured with near-infrared spectroscopy is stable in the muscle-relaxed, intubated patients and the awake and non-sedated patient. In case of participation the bladder pressure and the regional intestinal oxygen saturation (measured with near-infrared spectroscopy) will each be measured once intraoperatively and once postoperatively. Patients included in this study will be undergoing an operation which necessitates muscle-relaxation, as well as an indwelling urinary catheter during the operation and for a short-time thereafter for other reasons than this study.

NCT ID: NCT05830721 Recruiting - Clinical trials for Extracorporeal Membrane Oxygenation Complication

Continuous Compartment Pressure Monitoring for Compartment Syndrome in VA-ECMO Patients

VA-ECMO
Start date: January 2, 2024
Phase: N/A
Study type: Interventional

Acute compartment syndrome (ACS) is a surgical emergency that can develop in patients on extracorporeal membrane oxygenation (ECMO). ACS is a type of limb ischemia, which means that the limb, such as the arm or leg, loses blood flow. Patients on ECMO can develop this condition for many reasons, but most commonly from the ECMO procedure itself. This most commonly involves the leg. Key symptoms of ACS include severe pain, loss of pulses, loss of feeling, and inability to move the limb. However, because patients on ECMO are often sedated, ACS is difficult to diagnose as patients can not report symptoms. As a result, the only available tool for diagnosing ACS may be measurement of pressures in the limb. This is normally done with a needle-device, which is inserted into the leg for a single measurement. However, a recently developed device, called the MY01 Continuous Compartment Pressure Monitor, allows for continuous pressure readings instead of a single measurement. Multiple measurements may allow for much greater accuracy in diagnosing ACS, which may result in faster time to surgery and potentially save more limbs than single measurements. This device may also be less invasive than an older method of continuous pressure measuring, which uses a needle and tubing that is 14-gauge in size. Therefore, this study aims to compare 3 different types of methods for diagnosing ACS in patients on ECMO, which are 1) Standard of Care, 2) Standard of Care and MY01, and 3)Standard of Care and 14-gauge slit catheter.

NCT ID: NCT05672381 Recruiting - Clinical trials for Compartment Syndromes

NIRST and ICG-based Perfusion Imaging in Acute Compartment Syndrome

Start date: May 12, 2023
Phase:
Study type: Observational

This is a prospective observational study of patients with suspected Acute Compartment Syndrome. The primary objective of this work is to determine whether intensity changes associated with the NIRST signal, reflecting oxy- and deoxy-hemaglobin and water concentrations or ICG fluorescence signal, reflecting tissue perfusion, can be associated with development of Acute Compartment Syndrome and identification of at-risk soft tissue and muscle.

NCT ID: NCT05030259 Recruiting - Clinical trials for Acute Compartment Syndrome

The Research About the ACS After Femoropopliteal Arterial Injuries

Start date: September 1, 2021
Phase:
Study type: Observational

Crural Compartment syndrome is a well-known sequela after femoropopliteal arterial injuries in the lower extremity, particularly when there has been a long period of ischemia,need for ligation of a major vein, or when there is severe associated soft tissue.There is conteoversy in the treatment.

NCT ID: NCT04806555 Recruiting - Clinical trials for Compartment Syndrome of Leg

Diagnostic Value of Compression Ultrasound to Detect Acute Compartment Syndrome After Lower Limb Revascularisation

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

Acute compartment syndrome (ACS) after revascularization for acute limb ischemia is a potentially limb-threatening condition and requires urgent fasciotomy. Compression ultrasound (CU) is an established method for measuring intravenous pressure in superficial veins and, for example, can determine central venous pressure in critically ill patients. In cadaver studies, compression ultrasound has been proven to correlate with invasive intra compartmental pressure (ICP) measurements. This study aims to determine CU's added diagnostic value compared to ICP in detecting ACS after revascularisation.

NCT ID: NCT04674592 Recruiting - Tibia Fracture Clinical Trials

Biomarkers in the Diagnosis of Acute Compartment Syndrome

BioFACTS
Start date: April 5, 2018
Phase:
Study type: Observational

This prospective multinational, multicentre cohort study aims to investigate the hypothesis that biomarkers of muscle cell damage can predict acute compartment syndrome in patients with tibial fractures.

NCT ID: NCT04671173 Recruiting - Clinical trials for Acute Compartment Syndrome

Real-Time Muscle Pressure Measurements in Patients at Risk for Acute Compartment Syndrome

Start date: March 18, 2022
Phase: N/A
Study type: Interventional

The purpose of this trial is to conduct a pilot study that will aid in the design of an evaluation of the clinical benefit of MY01, an FDA cleared device, that allows continuous monitoring of intracompartmental muscle pressure in patients at risk for developing acute compartment syndrome. MY01 has previously been successfully tested on animal and Human cadaver Acute Compartment Syndrome models within the RI MUHC through Department of Defense research Grant (Combat Casualty Care Research Program (CCCRP). This trial is supported by the same grant, as the next phase of the overall project. This is a multi-center, non-randomized, historically controlled, prospective trial of the MY01 device. A cohort of 50 participants will be prospectively enrolled with two weeks follow up to document clinical benefit of the device. Results from this study will be used to inform the design of a larger study designed to demonstrate the clinical benefit of the MY01 device in the early diagnosis of ACS. The role of each organisation within the trial are detailed below: - Research Institute of McGill University Health Centre (RI MUHC): study coordination and data analysis (no recruitment activity will take place in the MUHC). - Hennepin Healthcare: participants recruitment - Vanderbilt University Medical Centre: participants recruitment