Focus on Analysis of Recovery in Oximetry

Intermittent Claudication Clinical Trial

— FARO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04376099
• Other study ID #: 2020/42
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Available exercise oximetry recording

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Intermittent Claudication

Intervention

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.

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	Transcutanesous oximetry DROP index 50% recovery time	Time for the DROP index to reach 50% of its minimal value from the end of walking	Maximum 30 minutes (duration of the recovery phase)
Secondary	Transcutanesous oximetry DROP index 90% recovery time	Time for the DROP index to reach 90% of its minimal value from the end of walking	Maximum 30 minutes (duration of the recovery phase)
Secondary	Concordance of pain and ischemia during the treadmill 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.	Maximum 60 minutes (duration of each test)