NCT04442672: MMCS

Early Diagnosis of Compartment Syndrome by Multimodal Detection Technique

Completed NA Last updated 22 June 2020

What this trial tests

NA trial testing acute compartment syndrome model of health volunteer in Compartment Syndrome of Leg in 25 participants. Completed in 10 August 2019.

Timeline

1 May 2019

Primary endpoint
10 August 2019

10 August 2019

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	25
Start date	1 May 2019
Primary completion	10 August 2019
Estimated completion	10 August 2019
Sites	1 location across China

Drugs / interventions tested

• acute compartment syndrome model of health volunteer
• sham

Conditions studied

• Compartment Syndrome of Leg — all drugs for Compartment Syndrome of Leg →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 60, any sex, with Compartment Syndrome of Leg. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

compartment syndrome has a high incidence in patients with a variety of diseases, including fractures, and delayed diagnosis or without intervention can lead to severe adverse prognosis, such as limb deformities, amputations and even death. Early diagnosis and early intervention are important, especially early diagnosis. Now, the diagnosis of compartment syndrome in clinical is based on medical history, clinical manifestations and measuring the compartment pressure by fine needle puncture. However, this diagnostic method is not easy to achieve early accurate diagnosis and non-invasive continuous monitoring. The study found that the increase of compartment pressure can lead to local changes of hemodynamic, tissue metabolism and nerve function. There are also studies and reports of near-infrared spectral tissue oxygen measurement technology, ultrasonic Doppler technology, near-infrared spectral pulse oxygen measurement technology and infrared thermal imaging technology can be used for noninvasive monitoring of acute compartment syndrome, but it is not clear that which is better above in early diagnosis of acute compartment syndrome.

The purpose of this study was to simulate the process of early pressure increase in the compartment by pressurizing the volunteers' calves by cuff, and then measured the tissue oxygen in the Anterior fascia compartment using a non-invasive monitor of the tissue oxygen parameters, the ultrasonic machine measured the blood flow signal of the upper and lower backbone blood vessels, and the blood oxygen meter to measure the blood saturation of the upper and lower ends of the limb. The infrared thermal imager measured the near and far limb temperature of the hemostatic belt and the two-point identification of the skin sensory nerve function at the far end of the fascia chamber. Then compare the correlation of these indicators with pressure changes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.