Early Diagnosis of Compartment Syndrome by Multimodal Detection Technique

NCT04442672 | Completed DMC

• 1 other identifier: I2019001099
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Compartment Syndrome of Leg

Keywords

compartment syndromes; multimodal; Ultrasonography; Near-Infrared Spectroscopy

Outcome Measures

Primary Outcomes (2)

• Blood flow spectrum of the radial artery and dorsal artery by ultrasound Doppler examination

  During the cuff compression, the blood flow spectrum of the radial artery and dorsal artery was recorded by the ultrasound, and analyzed later for the blood direction and duration.

  40 minutes

• tissue oxygen of the compartment by Infrared oxygen saturation monitor

  The infrared oxygen saturation monitor probe is placed on the anterior surface of the anterior fascia, and the changes of tissue oxygen index are continuously monitored during the process of cuff compression.

  40 minutes

Secondary Outcomes (4)

• temperture changes by near-infrared thermography

  40min

• Pulse oxygen

  40 minutes

• Systemic hemodynamics

  40 minutes

• Two-point identification check

  40 minutes

Study Arms (2)

compartment syndrome model group(CSM group)

EXPERIMENTAL

Procedure: acute compartment syndrome model of health volunteer

sham group

SHAM COMPARATOR

Procedure: sham

Interventions

acute compartment syndrome model of health volunteer PROCEDURE

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.

compartment syndrome model group(CSM group)

sham PROCEDURE

surrounding the cuff but not inflate it.

sham group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults, aged 18-60 years; No obvious cardiovascular diseases such as cardiovascular and cerebrovascular diseases; Complete limbs without deformity and no history of lower limb trauma; Informed consent

You may not qualify if:

• pregnancy or use of oral contraceptives; History of diabetes; History of deep vein thrombosis; Peripheral neuropathy; peripheral vascular disease; History of rhabdomyolysis

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, Zhejiang University School of Medicine Institute of Emergency Medicine, Zhejiang University

Hanzhou, Zhejiang, 310009, China

Location

Related Publications (31)

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MeSH Terms

Conditions

Compartment Syndromes

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mao Zhang, PHD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 22, 2020
• Study Start: May 1, 2019
• Primary Completion: August 10, 2019
• Study Completion: August 10, 2019
• Last Updated: June 22, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)