- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04442672
Early Diagnosis of Compartment Syndrome by Multimodal Detection Technique (MMCS)
The Value of Multimodal Monitoring in the Treatment of Compartment Syndrome: a Study Based on Healthy Volunteers
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zhejiang
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Hanzhou, Zhejiang, China, 310009
- 2nd Affiliated Hospital, Zhejiang University School of Medicine Institute of Emergency Medicine, Zhejiang University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- pregnancy or use of oral contraceptives; History of diabetes; History of deep vein thrombosis; Peripheral neuropathy; peripheral vascular disease; History of rhabdomyolysis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: compartment syndrome model group(CSM group)
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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.
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Sham Comparator: sham group
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surrounding the cuff but not inflate it.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood flow spectrum of the radial artery and dorsal artery by ultrasound Doppler examination
Time Frame: 40 minutes
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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.
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40 minutes
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tissue oxygen of the compartment by Infrared oxygen saturation monitor
Time Frame: 40 minutes
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
temperture changes by near-infrared thermography
Time Frame: 40min
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The temperature of the proximal and distal skin of the fascial compartment is continuously monitored by near-infrared thermography
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40min
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Pulse oxygen
Time Frame: 40 minutes
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the pulse oxygen of right middle finger, lower limbs, middle toe finger is continuously monitored
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40 minutes
|
Systemic hemodynamics
Time Frame: 40 minutes
|
heart rate, blood pressure is continuously monitored
|
40 minutes
|
Two-point identification check
Time Frame: 40 minutes
|
Two-point identification check of the back of foot is monitored during each pressure level
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40 minutes
|
Collaborators and Investigators
Investigators
- Study Chair: Mao Zhang, PHD, Second Affiliated Hospital, School of Medicine, Zhejiang University
Publications and helpful links
General Publications
- Shadgan B, Menon M, Sanders D, Berry G, Martin C Jr, Duffy P, Stephen D, O'Brien PJ. Current thinking about acute compartment syndrome of the lower extremity. Can J Surg. 2010 Oct;53(5):329-34.
- Shadgan B, Pereira G, Menon M, Jafari S, Darlene Reid W, O'Brien PJ. Risk factors for acute compartment syndrome of the leg associated with tibial diaphyseal fractures in adults. J Orthop Traumatol. 2015 Sep;16(3):185-92. doi: 10.1007/s10195-014-0330-y. Epub 2014 Dec 28.
- Olson SA, Glasgow RR. Acute compartment syndrome in lower extremity musculoskeletal trauma. J Am Acad Orthop Surg. 2005 Nov;13(7):436-44. doi: 10.5435/00124635-200511000-00003.
- McQueen MM, Duckworth AD. The diagnosis of acute compartment syndrome: a review. Eur J Trauma Emerg Surg. 2014 Oct;40(5):521-8. doi: 10.1007/s00068-014-0414-7. Epub 2014 Jun 3.
- Mubarak SJ, Hargens AR. Acute compartment syndromes. Surg Clin North Am. 1983 Jun;63(3):539-65. doi: 10.1016/s0039-6109(16)43030-6. No abstract available.
- von Keudell AG, Weaver MJ, Appleton PT, Bae DS, Dyer GSM, Heng M, Jupiter JB, Vrahas MS. Diagnosis and treatment of acute extremity compartment syndrome. Lancet. 2015 Sep 26;386(10000):1299-1310. doi: 10.1016/S0140-6736(15)00277-9. Erratum In: Lancet. 2015 Nov 7;386(10006):1824. Appelton, Paul T [corrected to Appleton, Paul T]. Lancet. 2015 Nov 7;386(10006):1824.
- Soller BR, Yang Y, Soyemi OO, Ryan KL, Rickards CA, Walz JM, Heard SO, Convertino VA. Noninvasively determined muscle oxygen saturation is an early indicator of central hypovolemia in humans. J Appl Physiol (1985). 2008 Feb;104(2):475-81. doi: 10.1152/japplphysiol.00600.2007. Epub 2007 Nov 15.
- Mancini DM, Bolinger L, Li H, Kendrick K, Chance B, Wilson JR. Validation of near-infrared spectroscopy in humans. J Appl Physiol (1985). 1994 Dec;77(6):2740-7. doi: 10.1152/jappl.1994.77.6.2740.
- Shuler MS, Reisman WM, Kinsey TL, Whitesides TE Jr, Hammerberg EM, Davila MG, Moore TJ. Correlation between muscle oxygenation and compartment pressures in acute compartment syndrome of the leg. J Bone Joint Surg Am. 2010 Apr;92(4):863-70. doi: 10.2106/JBJS.I.00816.
- Breit GA, Gross JH, Watenpaugh DE, Chance B, Hargens AR. Near-infrared spectroscopy for monitoring of tissue oxygenation of exercising skeletal muscle in a chronic compartment syndrome model. J Bone Joint Surg Am. 1997 Jun;79(6):838-43. doi: 10.2106/00004623-199706000-00006.
- Cathcart CC, Shuler MS, Freedman BA, Reno LR, Budsberg SC. Correlation of near-infrared spectroscopy and direct pressure monitoring in an acute porcine compartmental syndrome model. J Orthop Trauma. 2014 Jun;28(6):365-9. doi: 10.1097/BOT.0b013e3182a75ceb.
- Gentilello LM, Sanzone A, Wang L, Liu PY, Robinson L. Near-infrared spectroscopy versus compartment pressure for the diagnosis of lower extremity compartmental syndrome using electromyography-determined measurements of neuromuscular function. J Trauma. 2001 Jul;51(1):1-8, discussion 8-9. doi: 10.1097/00005373-200107000-00001.
- Arbabi S, Brundage SI, Gentilello LM. Near-infrared spectroscopy: a potential method for continuous, transcutaneous monitoring for compartmental syndrome in critically injured patients. J Trauma. 1999 Nov;47(5):829-33. doi: 10.1097/00005373-199911000-00002.
- Schmidt AH, Bosse MJ, Obremskey WT, O'Toole RV, Carroll EA, Stinner DJ, Hak DJ, Karunakar M, Hayda R, Frey KP, Di J, Zipunnikov V, MacKenzie E; Major Extremity Trauma Research Consortium (METRC). Continuous Near-Infrared Spectroscopy Demonstrates Limitations in Monitoring the Development of Acute Compartment Syndrome in Patients with Leg Injuries. J Bone Joint Surg Am. 2018 Oct 3;100(19):1645-1652. doi: 10.2106/JBJS.17.01495. Erratum In: J Bone Joint Surg Am. 2018 Dec 5;100(23):e151.
- Garr JL, Gentilello LM, Cole PA, Mock CN, Matsen FA 3rd. Monitoring for compartmental syndrome using near-infrared spectroscopy: a noninvasive, continuous, transcutaneous monitoring technique. J Trauma. 1999 Apr;46(4):613-6; discussion 617-8. doi: 10.1097/00005373-199904000-00009.
- Lima A, Bakker J. Near-infrared spectroscopy for monitoring peripheral tissue perfusion in critically ill patients. Rev Bras Ter Intensiva. 2011 Sep;23(3):341-51. English, Portuguese.
- Boezeman RP, Becx BP, van den Heuvel DA, Unlu C, Vos JA, de Vries JP. Monitoring of Foot Oxygenation with Near-infrared Spectroscopy in Patients with Critical Limb Ischemia Undergoing Percutaneous Transluminal Angioplasty: A Pilot Study. Eur J Vasc Endovasc Surg. 2016 Nov;52(5):650-656. doi: 10.1016/j.ejvs.2016.07.020. Epub 2016 Sep 7.
- Feldman F, Nickoloff EL. Normal thermographic standards for the cervical spine and upper extremities. Skeletal Radiol. 1984;12(4):235-49. doi: 10.1007/BF00349505.
- Uematsu S, Edwin DH, Jankel WR, Kozikowski J, Trattner M. Quantification of thermal asymmetry. Part 1: Normal values and reproducibility. J Neurosurg. 1988 Oct;69(4):552-5. doi: 10.3171/jns.1988.69.4.0552.
- Thangam S, Vaz M, Kurpad AV, Shetty PS. Superficial thermal gradients during mild body cooling and its relationship to forearm blood flow. Indian J Physiol Pharmacol. 1993 Oct;37(4):328-32.
- Katz LM, Nauriyal V, Nagaraj S, Finch A, Pearlstein K, Szymanowski A, Sproule C, Rich PB, Guenther BD, Pearlstein RD. Infrared imaging of trauma patients for detection of acute compartment syndrome of the leg. Crit Care Med. 2008 Jun;36(6):1756-61. doi: 10.1097/CCM.0b013e318174d800.
- Theuma F, Cassar K. The use of smartphone-attached thermography camera in diagnosis of acute lower limb ischemia. J Vasc Surg. 2018 Apr;67(4):1297. doi: 10.1016/j.jvs.2017.02.054. No abstract available.
- Lin PH, Saines M. Assessment of lower extremity ischemia using smartphone thermographic imaging. J Vasc Surg Cases Innov Tech. 2017 Oct 14;3(4):205-208. doi: 10.1016/j.jvscit.2016.10.012. eCollection 2017 Dec.
- Turnipseed WD, Hurschler C, Vanderby R Jr. The effects of elevated compartment pressure on tibial arteriovenous flow and relationship of mechanical and biochemical characteristics of fascia to genesis of chronic anterior compartment syndrome. J Vasc Surg. 1995 May;21(5):810-6; discussion 816-7. doi: 10.1016/s0741-5214(05)80012-6.
- Wiebe S, Kellenberger CJ, Khoury A, Miller SF. Early Doppler changes in a renal transplant patient secondary to abdominal compartment syndrome. Pediatr Radiol. 2004 May;34(5):432-4. doi: 10.1007/s00247-003-1094-3. Epub 2003 Dec 17.
- Kirkpatrick AW, Colistro R, Laupland KB, Fox DL, Konkin DE, Kock V, Mayo JR, Nicolaou S. Renal arterial resistive index response to intraabdominal hypertension in a porcine model. Crit Care Med. 2007 Jan;35(1):207-13. doi: 10.1097/01.CCM.0000249824.48222.B7.
- Auerbach DN, Bowen AD 3rd. Sonography of leg in posterior compartment syndrome. AJR Am J Roentgenol. 1981 Feb;136(2):407-8. doi: 10.2214/ajr.136.2.407. No abstract available.
- Mc Loughlin S, Mc Loughlin MJ, Mateu F. Pulsed Doppler in simulated compartment syndrome: a pilot study to record hemodynamic compromise. Ochsner J. 2013 Winter;13(4):500-6.
- Rosales-Velderrain A, Padilla M, Choe CH, Hargens AR. Increased microvascular flow and foot sensation with mild continuous external compression. Physiol Rep. 2013 Dec 19;1(7):e00157. doi: 10.1002/phy2.157. eCollection 2013 Dec 1.
- Clayton JM, Hayes AC, Barnes RW. Tissue pressure and perfusion in the compartment syndrome. J Surg Res. 1977 Apr;22(4):333-9. doi: 10.1016/0022-4804(77)90152-4. No abstract available.
- Lynch JE, Lynch JK, Cole SL, Carter JA, Hargens AR. Noninvasive monitoring of elevated intramuscular pressure in a model compartment syndrome via quantitative fascial motion. J Orthop Res. 2009 Apr;27(4):489-94. doi: 10.1002/jor.20778.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I2019001099
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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