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NCT04369781 Clinical Trial

Critical Limb Ischemia and Transcutaneous Oximetry

Critical Limb Ischemia Clinical Trial

— CITRA  

Official title:
Oximetrie Transcutanee et Ischemie Critique

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04369781
Other study ID # 2019-44
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 15, 2018
Est. completion date October 2022

Study information
Verified date June 2021
Source University Hospital, Angers
Contact Pierre ABRAHAM, MD PhD
Phone +33241353689
Email piabraham@chu-angers.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Retrospective analysis of transcutanesou oximetry (Tcpo2) recording for patients referred with suspected critical limb ischemia searching for specific changes in TcpO2 patterns.

Description:

- Patients had Tcpo2 recording at the suspected limb and chest level at rest in the lying position. - Provocative tests (leg elevation, leg lowering, oxygen inhalation) were performed to improve the sensitivity of tests. - TcpO2 results were recorded on a 1 Hz bais for of line analysis after anonymization. - We recorded age , gender, weight, height, ongoing treatments , History of cardiac or respiratory disease. Visual and mathematical analysis of the TcpO2 recording at the chest and limb level searching for various indices of TcpO2 variability at rest, or differences in responses between the chest and limb tcpO2 responses to provocative tests..

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date October 2022
Est. primary completion date October 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Referral for suspected critical limb ischemia Exclusion Criteria: - Absence of recording, deny to use medical file

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• transcutaneous oxygen pressure recording at rest
Recording of limb and chest transcutaneous oxygen pressure

Locations
Country Name City State
France University Hospital Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Variability of TcpO2 Study of TcpO2 variability 1 hour
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