Compartment Syndrome of LegNCT04806555
Diagnostic Value of Compression Ultrasound to Detect Acute Compartment Syndrome After Lower Limb Revascularisation
A study testing Compression ultrasound examination in people with Compartment Syndrome of Leg, run by Kantonsspital Aarau at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compartment Syndrome of Leg
- What is being tested?
- Compression ultrasound examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2021to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical suspicion of acute compartment syndrome after revascularisation of lower limb
Who cannot join
- Not fulfilling any of the inclusion criteria
- Patients refusing to participate
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, Canton of Aargau, 5001
Andrej Isaak, Dr.med., +4162 838 45 68, andrej.isaak@ksa.ch
About this study
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.
Read the 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.
- Conditions
- Compartment Syndrome of Leg
- Being tested
- Compression ultrasound examination
- Keywords
- compartment syndrome, acute limb ischemia, intra compartmental pressure, compression ultrasound, vascular surgery, limb revascularisation
- Medical subject headings
- Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Compression ultrasound | Experimental | All recruited patients Receives: Diagnostic Test: Compression ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elasticity ratio (ER)
Sensitivity and specificity of elasticity ratio measured by compression ultrasound for detecting high intra compartmental pressure
Measured: baseline
Secondary outcomes (1)
Inter- and intra-rater reliability
Inter- and intra-rater reliability of compression ultrasound
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Feb 2021
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Compartment Syndrome of LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrej Isaak, Kantonsspital Aarau
- Investigators
- Andrej Isaak, Dr.med., Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806555
- Sponsor's protocol ID
- 2020-03006
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 17936158Thalhammer 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.
PubMed 25346188Bloch 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.
PubMed 29195681Sellei 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.
PubMed 31784057
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Compression Ultrasound to Detect Acute Compartment Syndrome After Lower Limb Revascularisation
- ClinicalTrials.gov ID
- NCT04806555
- Acronym / sponsor ID
- 2020-03006
- Conditions
- Compartment Syndrome of Leg
- Keywords
- compartment syndrome, acute limb ischemia, intra compartmental pressure, compression ultrasound, vascular surgery, limb revascularisation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compression ultrasound | Experimental | Diagnostic Test: Compression ultrasound examinationAll recruited patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical suspicion of acute compartment syndrome after revascularisation of lower limb
Key exclusion criteria (2 listed)
- Not fulfilling any of the inclusion criteria
- Patients refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compression ultrasound examinationAfter 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. | Diagnostic test | Compression ultrasound |
Primary outcome
Elasticity ratio (ER)
Time frame: baseline
Sensitivity and specificity of elasticity ratio measured by compression ultrasound for detecting high intra compartmental pressure
1 secondary outcome
Inter- and intra-rater reliability
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 17936158Thalhammer 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.
- Background: PubMed 25346188Thalhammer 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.
- Background: PubMed 29195681Bloch 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.
- Background: PubMed 31784057Sellei 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.
- Individual participant dataSharing planned: No
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Compartment Syndromes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrej Isaak, Dr.med. principal investigator
Kantonsspital Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compression ultrasound examination in people with Compartment Syndrome of Leg, run by Kantonsspital Aarau at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrej Isaak, Dr.med. (+4162 838 4568, andrej.isaak@ksa.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elasticity ratio (ER) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04806555, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.