Diagnostic Value of Compression Ultrasound to Detect Acute Compartment Syndrome After Lower Limb Revascularisation

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.

Study Overview

• Status: Recruiting
• Conditions: Compartment Syndrome of Leg
• Intervention / Treatment: Diagnostic test: Compression ultrasound examination

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.

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrej Isaak, Dr.med.; Phone Number: +4162 838 4568; Email: andrej.isaak@ksa.ch

Study Locations

• Switzerland
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Recruiting
      • Kantonsspital Aarau
      • Contact: Andrej Isaak, Dr.med.; Phone Number: +4162 838 45 68; Email: andrej.isaak@ksa.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Compression ultrasound; All recruited patients

Diagnostic test: Compression ultrasound examination; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elasticity ratio (ER)	Sensitivity and specificity of elasticity ratio measured by compression ultrasound for detecting high intra compartmental pressure	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter- and intra-rater reliability	Inter- and intra-rater reliability of compression ultrasound	baseline

Collaborators and Investigators

• Sponsor: Kantonsspital Aarau
• Investigators: Principal Investigator: Andrej Isaak, Dr.med., Kantonsspital Aarau

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: compartment syndrome; vascular surgery; acute limb ischemia; intra compartmental pressure; compression ultrasound; limb revascularisation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Musculoskeletal Diseases; Muscular Diseases; Syndrome; Compartment Syndromes
• Other Study ID Numbers: 2020-03006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No