CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
acute compartment syndrome model of health volunteer +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04442672
NCT04442672N/ACompleted

The Value of Multimodal Monitoring in the Treatment of Compartment Syndrome: a Study Based on Healthy Volunteers

Second Affiliated Hospital, School of Medicine, Zhejiang University·interventional·Posted Jun 22, 2020·Updated Jun 22, 2020

In Brief

A clinical study evaluating acute compartment syndrome model of health volunteer and sham for Compartment Syndrome of Leg. Completed, enrolled 25 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 22, 2020
Enrollment StartMay 1, 2019
Primary CompletionAug 10, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.0 years ago

Interventions

acute compartment syndrome model of health volunteerprocedure

the acute compartment syndrome model of health volunteer is induced by pressurizing the calves by the cuff, and the cuff is inflated and pressurized to a pressure value of 20, 30, 40, 50, 60, 70, 80 mmHg. the pressure inside the cuff was up to 10 s during pressurization and maintained stable for 1 min, measured and the above indicators were recorded within 3 min.

shamprocedure

surrounding the cuff but not inflate it.