Skip to content

Focus on Analysis of Recovery in Oximetry

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04376099
Acronym
FARO
Enrollment
1000
Registered
2020-05-06
Start date
2018-01-01
Completion date
2019-12-31
Last updated
2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent Claudication

Brief 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.

Interventions

DIAGNOSTIC_TESTTranscutaneous 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.

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Available exercise oximetry recording

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Transcutanesous oximetry DROP index 50% recovery timeMaximum 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

MeasureTime frameDescription
Transcutanesous oximetry DROP index 90% recovery timeMaximum 30 minutes (duration of the recovery phase)Time for the DROP index to reach 90% of its minimal value from the end of walking
Concordance of pain and ischemia during the treadmill testMaximum 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026