Focus on Analysis of Recovery in Oximetry

Completed

• Conditions: Intermittent Claudication
• Interventions: Diagnostic Test: Transcutaneous oxygen pressure measurement during the treadmill test

• Registration Number: NCT04376099
• Lead Sponsor: University Hospital, Angers

Brief Summary

Analysis of localizations for symptoms and ischemia on treadmill and of the recovery profiles of patients that have had an exercise oximetry

Detailed Description

Patients referred for exercise oximetry have buttocks thighs and calves recording during exercise and in the recovery period for a minimum of 10 minutes.

For each limb probe the decrease from rest of oxygen pressure (DROP) index is calculated as a subtraction of chest changes from limb changes throughout rest, exercise and recovery. DROP was measured as a routine on buttocks, thighs and calves and a minimal DROP lower than minus 15 mmHg considered indicative of the presence of regional blood flow impairment (ischemia) in the considered area.

Recordings and patients characteristics are recorded on a institutionally validated database.

A comparison will be performed of symptoms by history to symptoms reported on treadmill and hemodynamic results attained through DROP values.

Re-analysis of the recordings after ethical approval will be performed in an aim at estimating the duration of 50% and 90% recovery of DROP at the different levels (buttocks tigh and calves) to account for hemodynamic impairmenty not only at the calf (calves) level.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-04
• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-05-01
• Last Update Submitted: 2020-05-01
• Study First Posted: 2020-05-06
• Last Update Posted: 2020-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Available exercise oximetry recording

Exclusion Criteria

• Deny of the use of the medical file from the patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exercise oximetry	Transcutaneous oxygen pressure measurement during the treadmill test	Patients complaining claudication and referred for exercise diagnostic oximetry. Exercise oximetry are performed on treadmill (3.2km/h, 10% slope)

Primary Outcome Measures

Name	Time	Method
Transcutanesous oximetry DROP index 50% recovery time	Maximum 30 minutes (duration of the recovery phase)	Time for the DROP index to reach 50% of its minimal value from the end of walking

Secondary Outcome Measures

Name	Time	Method
Transcutanesous oximetry DROP index 90% recovery time	Maximum 30 minutes (duration of the recovery phase)	Time for the DROP index to reach 90% of its minimal value from the end of walking
Concordance of pain and ischemia during the treadmill test	Maximum 60 minutes (duration of each test)	Observation of calf and non calf pain and calf and non-calf ischemia in patients reporting calf pain by history. Ischemia being defined as a minimal DROP value lower than minus 15 mmHg.; Analysis of the concordance of localizations of pain and ischemia.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Angers, France