Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04806555
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2021-03-10
Brief Title:
Diagnostic Value of Compression Ultrasound to Detect Acute Compartment Syndrome After Lower Limb Revascularisation
Sponsor:
Kantonsspital Aarau
Organization:
Kantonsspital Aarau
Study Overview
Official Title:
Diagnostic Value of Compression Ultrasound to Detect Acute Compartment Syndrome After Lower Limb Revascularisation
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 CUs 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 944 and a specificity of 889 to diagnose a compartment syndrome properly The first results in six trauma patients showed that the ER less than 105 of the anterior tibial compartment had a sensitivity of 958 and a specificity of 875 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 CUs added diagnostic value compared to ICP in detecting ACS after revascularisation
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 944 and a specificity of 889 to diagnose a compartment syndrome properly The first results in six trauma patients showed that the ER less than 105 of the anterior tibial compartment had a sensitivity of 958 and a specificity of 875 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 CUs added diagnostic value compared to ICP in detecting ACS after revascularisation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None