NCT04806555

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

March 10, 2021

Last Update Submit

March 29, 2022

Conditions

Compartment Syndrome of Leg

Keywords

compartment syndromeacute limb ischemiaintra compartmental pressurecompression ultrasoundvascular surgerylimb revascularisation

Outcome Measures

Primary Outcomes (1)

  • Elasticity ratio (ER)

    Sensitivity and specificity of elasticity ratio measured by compression ultrasound for detecting high intra compartmental pressure

    baseline

Secondary Outcomes (1)

  • Inter- and intra-rater reliability

    baseline

Study Arms (1)

Compression ultrasound

EXPERIMENTAL

All recruited patients

Diagnostic Test: Compression ultrasound examination

Interventions

Compression ultrasound examinationDIAGNOSTIC_TEST

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.

Compression ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical suspicion of acute compartment syndrome after revascularisation of lower limb

You may not qualify if:

  • Patients refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

Related Publications (4)

  • 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.

    PMID: 17936158BACKGROUND

  • 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.

    PMID: 25346188BACKGROUND

  • 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.

    PMID: 29195681BACKGROUND

  • 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.

    PMID: 31784057BACKGROUND

MeSH Terms

Conditions

Compartment Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Andrej Isaak, Dr.med.

    Kantonsspital Aarau

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrej Isaak, Dr.med.

CONTACT

+4162 838 4568andrej.isaak@ksa.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Vascular Surgery

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 19, 2021

Study Start

February 1, 2021

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)