<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04442672</url>
  </required_header>
  <id_info>
    <org_study_id>I2019001099</org_study_id>
    <nct_id>NCT04442672</nct_id>
  </id_info>
  <brief_title>Early Diagnosis of Compartment Syndrome by Multimodal Detection Technique</brief_title>
  <acronym>MMCS</acronym>
  <official_title>The Value of Multimodal Monitoring in the Treatment of Compartment Syndrome: a Study Based on Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      compartment syndrome has a high incidence in patients with a variety of diseases, including&#xD;
      fractures, and delayed diagnosis or without intervention can lead to severe adverse&#xD;
      prognosis, such as limb deformities, amputations and even death. Early diagnosis and early&#xD;
      intervention are important, especially early diagnosis. Now, the diagnosis of compartment&#xD;
      syndrome in clinical is based on medical history, clinical manifestations and measuring the&#xD;
      compartment pressure by fine needle puncture. However, this diagnostic method is not easy to&#xD;
      achieve early accurate diagnosis and non-invasive continuous monitoring. The study found that&#xD;
      the increase of compartment pressure can lead to local changes of hemodynamic, tissue&#xD;
      metabolism and nerve function. There are also studies and reports of near-infrared spectral&#xD;
      tissue oxygen measurement technology, ultrasonic Doppler technology, near-infrared spectral&#xD;
      pulse oxygen measurement technology and infrared thermal imaging technology can be used for&#xD;
      noninvasive monitoring of acute compartment syndrome, but it is not clear that which is&#xD;
      better above in early diagnosis of acute compartment syndrome.&#xD;
&#xD;
      The purpose of this study was to simulate the process of early pressure increase in the&#xD;
      compartment by pressurizing the volunteers' calves by cuff, and then measured the tissue&#xD;
      oxygen in the Anterior fascia compartment using a non-invasive monitor of the tissue oxygen&#xD;
      parameters, the ultrasonic machine measured the blood flow signal of the upper and lower&#xD;
      backbone blood vessels, and the blood oxygen meter to measure the blood saturation of the&#xD;
      upper and lower ends of the limb. The infrared thermal imager measured the near and far limb&#xD;
      temperature of the hemostatic belt and the two-point identification of the skin sensory nerve&#xD;
      function at the far end of the fascia chamber. Then compare the correlation of these&#xD;
      indicators with pressure changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants is health volunteers, age 18-60 years. When the participants agree to&#xD;
      participate in the experiment, the experimenter first needs to explain the experimental&#xD;
      process to the participants, and ask the participants to agree and sign the informed consent&#xD;
      before they can conduct the experiment. The experiment was conducted in the emergency&#xD;
      medicine department of a university-affiliated top three hospital.&#xD;
&#xD;
      When the participants are included in the experimental study, the general demographic&#xD;
      information of the participants, such as name, gender, age, etc., is first collected. Ensure&#xD;
      the experimental environment is comfortable, ambient temperature 20-24℃, ambient humidity&#xD;
      50-60%. Participants have loose clothing on their lower limbs to avoid pressure on their&#xD;
      limbs. Take the supine position, keep the calf hanging, support the heel, make the calf level&#xD;
      flush with the heart, rest for 5 minutes.&#xD;
&#xD;
      The monitor (M3002A, Philips Medizin Systeme Boeblingen GmbH, Germany) was used to&#xD;
      continuously monitor the electrocardiogram, the left upper arm measured blood pressure (BP),&#xD;
      and the right middle finger to monitor pulse oximetry (SpO2). The calf circumference was&#xD;
      measured at the midpoint of the bilateral humerus with a soft ruler. The maximum thickness of&#xD;
      anterior fascia compartment was measured at the midpoint of the tibia using an ultrasonic&#xD;
      machine (Acclarix AX8, Shenzhen Libang Precision Instrument Co., Ltd., China).&#xD;
&#xD;
      The random number table method selects one side of the calf as the experimental side and the&#xD;
      opposite side as the control side.&#xD;
&#xD;
      (8) The following parameters were recorded at baseline (pressure 0mmHg in the calf tourniquet&#xD;
      on both sides): (1) heart rate, blood pressure; (2) right middle finger, lower limbs, middle&#xD;
      toe finger vein oxygen SpO2; (3) bilateral Local blood tissue parameters (TOI, THI, ΔCHb,&#xD;
      CHbO2, ΔCtHb) in the calf; (4) Near-infrared thermography temperature values (T-u1, T-u2) in&#xD;
      the knee and thighs of the lower leg and the instep and toe Near-infrared thermography&#xD;
      temperature values (T-d1, T-d2); (5) bilateral radial artery ultrasound Doppler measurement&#xD;
      parameters (D-pa, S-pa, Vs-pa, Vd-pa, DRAF-pa) Ultrasound Doppler measurement parameters of&#xD;
      bilateral iliac veins (D-pv, S-pv, Vs-pv, Vd-pv), bilateral posterior tibial artery and&#xD;
      dorsal artery ultrasound Doppler measurement parameters (Vs-pta, Vd -pta, SFAF-pta, Vs-da,&#xD;
      Vd-da, SFAF-da). (6) Two-point identification threshold TPD.&#xD;
&#xD;
      In turn, the experimental side calf tourniquet was inflated and pressurized to a pressure&#xD;
      value of 20, 30, 40, 50, 60, 70, 80 mmHg, and the pressure inside the tourniquet was up to 10&#xD;
      s during pressurization, and maintained stable for 1 min, measured and the above indicators&#xD;
      were recorded within 3 min. During the experiment, the subjects were closely monitored for&#xD;
      adverse reactions. At the end of the study, the observation was continued for 30 minutes, and&#xD;
      the drinking water was at least 500 ml, and the limb sensation, pain and urine color were&#xD;
      continuously observed within 24 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">August 10, 2019</completion_date>
  <primary_completion_date type="Actual">August 10, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood flow spectrum of the radial artery and dorsal artery by ultrasound Doppler examination</measure>
    <time_frame>40 minutes</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>tissue oxygen of the compartment by Infrared oxygen saturation monitor</measure>
    <time_frame>40 minutes</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>temperture changes by near-infrared thermography</measure>
    <time_frame>40min</time_frame>
    <description>The temperature of the proximal and distal skin of the fascial compartment is continuously monitored by near-infrared thermography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulse oxygen</measure>
    <time_frame>40 minutes</time_frame>
    <description>the pulse oxygen of right middle finger, lower limbs, middle toe finger is continuously monitored</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic hemodynamics</measure>
    <time_frame>40 minutes</time_frame>
    <description>heart rate, blood pressure is continuously monitored</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Two-point identification check</measure>
    <time_frame>40 minutes</time_frame>
    <description>Two-point identification check of the back of foot is monitored during each pressure level</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Compartment Syndrome of Leg</condition>
  <arm_group>
    <arm_group_label>compartment syndrome model group(CSM group)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>acute compartment syndrome model of health volunteer</intervention_name>
    <description>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.</description>
    <arm_group_label>compartment syndrome model group(CSM group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sham</intervention_name>
    <description>surrounding the cuff but not inflate it.</description>
    <arm_group_label>sham group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults, aged 18-60 years; No obvious cardiovascular diseases such as&#xD;
             cardiovascular and cerebrovascular diseases; Complete limbs without deformity and no&#xD;
             history of lower limb trauma; Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy or use of oral contraceptives; History of diabetes; History of deep vein&#xD;
             thrombosis; Peripheral neuropathy; peripheral vascular disease; History of&#xD;
             rhabdomyolysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mao Zhang, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>2nd Affiliated Hospital, Zhejiang University School of Medicine Institute of Emergency Medicine, Zhejiang University</name>
      <address>
        <city>Hanzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
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  <verification_date>July 2019</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>compartment syndromes</keyword>
  <keyword>multimodal</keyword>
  <keyword>Ultrasonography</keyword>
  <keyword>Near-Infrared Spectroscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compartment Syndromes</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04442672
org study id: I2019001099
nct id: NCT04442672
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Blood flow spectrum of the radial artery and dorsal artery by ultrasound Doppler examination
time frame: 40 minutes
description: 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.
measure: tissue oxygen of the compartment by Infrared oxygen saturation monitor
time frame: 40 minutes
description: 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.
measure: temperture changes by near-infrared thermography
time frame: 40min
description: The temperature of the proximal and distal skin of the fascial compartment is continuously monitored by near-infrared thermography
measure: Pulse oxygen
time frame: 40 minutes
description: the pulse oxygen of right middle finger, lower limbs, middle toe finger is continuously monitored
measure: Systemic hemodynamics
time frame: 40 minutes
description: heart rate, blood pressure is continuously monitored
measure: Two-point identification check
time frame: 40 minutes
description: Two-point identification check of the back of foot is monitored during each pressure level
arm group label: compartment syndrome model group(CSM group)
arm group type: Experimental
arm group label: sham group
arm group type: Sham Comparator
intervention type: Procedure
intervention name: acute compartment syndrome model of health volunteer
description: 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.
arm group label: compartment syndrome model group(CSM group)
intervention type: Procedure
intervention name: sham
description: surrounding the cuff but not inflate it.
arm group label: sham group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mao Zhang, PHD
role: Study Chair
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
facility: 
country: China
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responsible party type: Sponsor
mesh term: Compartment Syndromes
mesh term: Syndrome
sharing ipd: No