Focus on Analysis of Recovery in Oximetry (FARO)

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

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

Study Overview

• Status: Completed
• Conditions: Intermittent Claudication
• Intervention / Treatment: Diagnostic test: Transcutaneous oxygen pressure measurement during the treadmill test

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 Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients referred for exercise oximetry for intermittent claudication

Description

Inclusion Criteria:

• Available exercise oximetry recording

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Exercise oximetry; Patients complaining claudication and referred for exercise diagnostic oximetry. Exercise oximetry are performed on treadmill (3.2km/h, 10% slope)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Pierre ABRAHAM, MD; PhD, UH in Angers (FRANCE)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Intermittent Claudication
• Other Study ID Numbers: 2020/42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data available under reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No