Vascular Compression Assessment Using Transcutaneous Oxymetry in Patients Suspected of Having Thoracic Outlet Syndrome

January 26, 2023 updated by: University Hospital, Angers

Apport de l'évaluation de l'ischémie de Membre supérieur Par oxymétrie transcutanée Dans la caractérisation de la Compression Vasculaire Chez Les Patients Suspects de Syndrome du défilé Thoraco-brachial

Thoracic outlet syndrome (TOS) is characterized by nervous, venous or arterial symptoms resulting from a compression of the thoracic bundle in the thoracic outlet. The diagnostic approach of TOS is still controversial. The investigating team is interested in arterial TOS and have already been able to demonstrate the presence of arm ischemia during dynamic maneuvers using transcutaneous oximetry (TcpO2). The correlation between the measurement of TcpO2 during dynamic maneuvers and the vascular compression type (arterial, venous or both) will be evaluated. The evaluation the correlation between TcpO2 and degree of arterial compression observed in dynamic arteriography (considered as a gold standard examination) will be calculated too. The use of TcpO2 could be developed in the diagnosis assessment of TOS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Chu Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Patient presenting to the vascular medicine department with suspected thoracic outlet syndrome.

Description

Inclusion Criteria:

  • patient suspected of having a thoracic outlet syndrome
  • patient having carried out additional examinations as part of the diagnostic assessment : venous and arterial Doppler or dynamic arteriography and venography
  • patient having carried out a dynamic TcpO2 recording

Exclusion Criteria:

  • patient under 18 year old
  • non french speaker
  • patient who expressed his/her refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients Suspected of Having Thoracic Outlet Syndrome
Patients who came for the diagnosis of TOS
Diagnostic test: Transcutaneous oximetry
Comparison of the TcpO2 values recorded during dynamic maneuver with the estimated rate of compression of the subclavian and axillary vessels determined on dynamic angiography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DROPmin according on the type of compression
Time Frame: thirty minutes

Variation in upper limb ischemia is estimated by TcpO2 measurement and calculating of the DROPmin (TcpO2 variation regarding a reference) depending on the type of damage (arterial, venous, or both arterial and venous).

DROP is Decrease Rest of Oxygen Pressure
thirty minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DROPmin according on the degree of arterial stenosis
Time Frame: thirty minutes
To assess the correlation between the severity of upper limb ischemia by TcpO2 measurement and the degree of arterial stenosis observed in diagnostic arteriography.
thirty minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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