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Completed

NCT Number: NCT04376099

Focus on Analysis of Recovery in Oximetry

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

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Key information

Conditions

Intermittent Claudication Cardiovascular Diseases Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital

Angers, 49933, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Available exercise oximetry recording

Exclusion criteria

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

Treatment and study plan

Transcutaneous oxygen pressure measurement during the treadmill test

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.

Primary outcomes

  1. Transcutanesous oximetry DROP index 50% recovery time

    Time frame: 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 outcomes

  1. Transcutanesous oximetry DROP index 90% recovery time

    Time frame: 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

  2. Concordance of pain and ischemia during the treadmill test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: FARO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 6, 2020
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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