NCT04376099

Focus on Analysis of Recovery in Oximetry

Focus Sur l'Analyse de la récupération en oxymétries transcutanées (French Language)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intermittent Claudication

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transcutaneous oxygen pressure measurement during the treadmill test	Calculation of the decrease from rest of oxygen pressure (DROP) throughout the period of rest exercise and recovery. The DROP is calculated as chanegs on each limb probe minus changes on a chest reference probe from rest. Analysis of the recovery period of the recordings will be done to seach for recovery 50% and 90% from the minimal DROP observed Evaluation of calf and non calf pain during the tests. Evaluation of calf and non calf (buttock or thigh) ischemia during the tests. Ischemia being defined as a monimal DROP lower than minus 15 mmHg.

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2020-05-06
• Last updated: 2020-05-06

Locations

1 site across 1 country: France