Early Diagnosis of Compartment Syndrome by Multimodal Detection Technique
NCT ID: NCT04442672
Last Updated: 2020-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2019-05-01
2019-08-10
Brief Summary
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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.
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Detailed Description
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When the participants are included in the experimental study, the general demographic information of the participants, such as name, gender, age, etc., is first collected. Ensure the experimental environment is comfortable, ambient temperature 20-24℃, ambient humidity 50-60%. Participants have loose clothing on their lower limbs to avoid pressure on their limbs. Take the supine position, keep the calf hanging, support the heel, make the calf level flush with the heart, rest for 5 minutes.
The monitor (M3002A, Philips Medizin Systeme Boeblingen GmbH, Germany) was used to continuously monitor the electrocardiogram, the left upper arm measured blood pressure (BP), and the right middle finger to monitor pulse oximetry (SpO2). The calf circumference was measured at the midpoint of the bilateral humerus with a soft ruler. The maximum thickness of anterior fascia compartment was measured at the midpoint of the tibia using an ultrasonic machine (Acclarix AX8, Shenzhen Libang Precision Instrument Co., Ltd., China).
The random number table method selects one side of the calf as the experimental side and the opposite side as the control side.
(8) The following parameters were recorded at baseline (pressure 0mmHg in the calf tourniquet on both sides): (1) heart rate, blood pressure; (2) right middle finger, lower limbs, middle toe finger vein oxygen SpO2; (3) bilateral Local blood tissue parameters (TOI, THI, ΔCHb, CHbO2, ΔCtHb) in the calf; (4) Near-infrared thermography temperature values (T-u1, T-u2) in the knee and thighs of the lower leg and the instep and toe Near-infrared thermography temperature values (T-d1, T-d2); (5) bilateral radial artery ultrasound Doppler measurement parameters (D-pa, S-pa, Vs-pa, Vd-pa, DRAF-pa) Ultrasound Doppler measurement parameters of bilateral iliac veins (D-pv, S-pv, Vs-pv, Vd-pv), bilateral posterior tibial artery and dorsal artery ultrasound Doppler measurement parameters (Vs-pta, Vd -pta, SFAF-pta, Vs-da, Vd-da, SFAF-da). (6) Two-point identification threshold TPD.
In turn, the experimental side calf tourniquet was inflated and pressurized to a pressure value of 20, 30, 40, 50, 60, 70, 80 mmHg, and the pressure inside the tourniquet was up to 10 s during pressurization, and maintained stable for 1 min, measured and the above indicators were recorded within 3 min. During the experiment, the subjects were closely monitored for adverse reactions. At the end of the study, the observation was continued for 30 minutes, and the drinking water was at least 500 ml, and the limb sensation, pain and urine color were continuously observed within 24 hours.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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compartment syndrome model group(CSM group)
acute compartment syndrome model of health volunteer
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.
sham group
sham
surrounding the cuff but not inflate it.
Interventions
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acute compartment syndrome model of health volunteer
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.
sham
surrounding the cuff but not inflate it.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
60 Years
ALL
Yes
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Mao Zhang, PHD
Role: STUDY_CHAIR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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2nd Affiliated Hospital, Zhejiang University School of Medicine Institute of Emergency Medicine, Zhejiang University
Hanzhou, Zhejiang, China
Countries
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References
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Other Identifiers
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I2019001099
Identifier Type: -
Identifier Source: org_study_id
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