Early Diagnosis of Compartment Syndrome by Multimodal Detection Technique
Condition: Compartment Syndrome of Leg
MeSH terms: Compartment Syndromes; Syndrome
Study type: Interventional

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.
    

Detailed description: 
      The participants is health volunteers, age 18-60 years. When the participants agree to
      participate in the experiment, the experimenter first needs to explain the experimental
      process to the participants, and ask the participants to agree and sign the informed consent
      before they can conduct the experiment. The experiment was conducted in the emergency
      medicine department of a university-affiliated top three hospital.

      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.
    

Intervention name(s): acute compartment syndrome model of health volunteer; sham
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; surrounding the cuff but not inflate it.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: compartment syndromes; multimodal; Ultrasonography; Near-Infrared Spectroscopy