Focus on Analysis of Recovery in Oximetry

NCT ID: NCT04376099

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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

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Intermittent Claudication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Exercise oximetry

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

Transcutaneous oxygen pressure measurement during the treadmill test

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Available exercise oximetry recording

Exclusion Criteria

* Deny of the use of the medical file from the patient
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre ABRAHAM, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

UH in Angers (FRANCE)

Locations

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University Hospital

Angers, , France

Site Status

Countries

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France

Other Identifiers

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2020/42

Identifier Type: -

Identifier Source: org_study_id

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