Diagnostic Value of Compression Ultrasound to Detect Acute Compartment Syndrome After Lower Limb Revascularisation
Primary Purpose
Compartment Syndrome of Leg
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Compression ultrasound examination
Sponsored by
About this trial
This is an interventional diagnostic trial for Compartment Syndrome of Leg focused on measuring compartment syndrome, acute limb ischemia, intra compartmental pressure, compression ultrasound, vascular surgery, limb revascularisation
Eligibility Criteria
Inclusion Criteria:
- Clinical suspicion of acute compartment syndrome after revascularisation of lower limb
Exclusion Criteria:
- Not fulfilling any of the inclusion criteria
- Patients refusing to participate
Sites / Locations
- Kantonsspital AarauRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Compression ultrasound
Arm Description
All recruited patients
Outcomes
Primary Outcome Measures
Elasticity ratio (ER)
Sensitivity and specificity of elasticity ratio measured by compression ultrasound for detecting high intra compartmental pressure
Secondary Outcome Measures
Inter- and intra-rater reliability
Inter- and intra-rater reliability of compression ultrasound
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04806555
Brief Title
Diagnostic Value of Compression Ultrasound to Detect Acute Compartment Syndrome After Lower Limb Revascularisation
Official Title
Diagnostic Value of Compression Ultrasound to Detect Acute Compartment Syndrome After Lower Limb Revascularisation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Aarau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Acute compartment syndrome (ACS) after revascularization for acute limb ischemia is a potentially limb-threatening condition and requires urgent fasciotomy. Compression ultrasound (CU) is an established method for measuring intravenous pressure in superficial veins and, for example, can determine central venous pressure in critically ill patients. In cadaver studies, compression ultrasound has been proven to correlate with invasive intra compartmental pressure (ICP) measurements. This study aims to determine CU's added diagnostic value compared to ICP in detecting ACS after revascularisation.
Detailed Description
Acute compartment syndrome (ACS) after revascularization for acute limb ischemia is a potentially limb-threatening condition and requires urgent fasciotomy. It occurs when the tissue pressure within a closed muscle compartment exceeds the perfusion pressure and results in muscle and nerve ischemia.
If clinically suspected, intra- compartmental pressure (ICP) is measured by inserting a needle into the area of ACS, usually the anterior tibial muscle compartment, while an attached pressure monitor records the pressure. This invasive diagnostic method is widely used as a standard with a sensitivity of 94% and specificity of 98%.
Compression ultrasound (CU) is an established method for measuring intravenous pressure in superficial veins and, for example, can determine central venous pressure in critically ill patients. An ultrasound translucent probe measures the pressure applied on the skin surface with the ultrasound transducer. In cadaver studies, compression ultrasound has been proven to correlate with invasive ICP measurements. The elasticity ratio (ER, compartment diameter with and without external pressure) validated in a recently published animal model has a sensitivity of 94.4% and a specificity of 88.9% to diagnose a compartment syndrome properly. The first results in six trauma patients showed that the ER less than 10,5% of the anterior tibial compartment had a sensitivity of 95,8% and a specificity of 87,5% to an appropriate diagnosis of ACS. Thus, this non-invasive, low-cost, and secure diagnostic technique has not been validated in patients with ACS after revascularisation for acute lower limb ischemia yet has the potential to discriminate clinically suspected ACS sensitively.
This study aims to determine CU's added diagnostic value compared to ICP in detecting ACS after revascularisation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compartment Syndrome of Leg
Keywords
compartment syndrome, acute limb ischemia, intra compartmental pressure, compression ultrasound, vascular surgery, limb revascularisation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Compression ultrasound
Arm Type
Experimental
Arm Description
All recruited patients
Intervention Type
Diagnostic Test
Intervention Name(s)
Compression ultrasound examination
Intervention Description
After successful revascularisation for acute ischemia and clinical suspicion of acute compartment syndrome, compression ultrasound (CU) will be performed in OR followed by standard intra-compartmental measurement. Two physicians will perform two subsequent measurements of the affected limb after revascularisation. The unaffected limb will be examined once to obtain baseline elasticity ratio values. All CU examinations will be documented in PACS (picture archiving and communication system) and evaluated after ICP measurement, and if necessary, fasciotomy is performed.
Primary Outcome Measure Information:
Title
Elasticity ratio (ER)
Description
Sensitivity and specificity of elasticity ratio measured by compression ultrasound for detecting high intra compartmental pressure
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Inter- and intra-rater reliability
Description
Inter- and intra-rater reliability of compression ultrasound
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical suspicion of acute compartment syndrome after revascularisation of lower limb
Exclusion Criteria:
Not fulfilling any of the inclusion criteria
Patients refusing to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrej Isaak, Dr.med.
Phone
+4162 838 4568
Email
andrej.isaak@ksa.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrej Isaak, Dr.med.
Organizational Affiliation
Kantonsspital Aarau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Aarau
City
Aarau
State/Province
Aargau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrej Isaak, Dr.med.
Phone
+4162 838 45 68
Email
andrej.isaak@ksa.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17936158
Citation
Thalhammer C, Aschwanden M, Odermatt A, Baumann UA, Imfeld S, Bilecen D, Marsch SC, Jaeger KA. Noninvasive central venous pressure measurement by controlled compression sonography at the forearm. J Am Coll Cardiol. 2007 Oct 16;50(16):1584-9. doi: 10.1016/j.jacc.2007.07.022. Epub 2007 Oct 1.
Results Reference
background
PubMed Identifier
25346188
Citation
Thalhammer C, Segerer S, Augustoni M, Jacomella V, Clemens RK, Wuthrich RP, Amann-Vesti BR, Husmann M. Acute effects of haemodialysis on central venous and arterial pressure characteristics. Nephrology (Carlton). 2015 Feb;20(2):91-5. doi: 10.1111/nep.12356.
Results Reference
background
PubMed Identifier
29195681
Citation
Bloch A, Tomaschett C, Jakob SM, Schwinghammer A, Schmid T. Compression sonography for non-invasive measurement of lower leg compartment pressure in an animal model. Injury. 2018 Mar;49(3):532-537. doi: 10.1016/j.injury.2017.11.036. Epub 2017 Nov 27.
Results Reference
background
PubMed Identifier
31784057
Citation
Sellei RM, Wollnitz J, Reinhardt N, de la Fuente M, Radermacher K, Weber C, Kobbe P, Hildebrand F. Non-invasive measurement of muscle compartment elasticity in lower limbs to determine acute compartment syndrome: Clinical results with pressure related ultrasound. Injury. 2020 Feb;51(2):301-306. doi: 10.1016/j.injury.2019.11.027. Epub 2019 Nov 21.
Results Reference
background
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Diagnostic Value of Compression Ultrasound to Detect Acute Compartment Syndrome After Lower Limb Revascularisation
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