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

NCT ID: NCT05702866

Last Updated: 2023-01-27

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thoracic Outlet Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients Suspected of Having Thoracic Outlet Syndrome

Patients who came for the diagnosis of TOS

Transcutaneous oximetry

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Angers

Angers, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-161

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.