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

NCT05702866 | Completed

• 1 other identifier: 2022-161
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thoracic Outlet Syndrome

Keywords

transcutaneous oximetry; thoracic outlet syndrome; arteriography; vascular compression

Outcome Measures

Primary Outcomes (1)

• DROPmin according on the type of compression

  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 Outcomes (1)

• DROPmin according on the degree of arterial stenosis

  thirty minutes

Study Arms (1)

Patients Suspected of Having Thoracic Outlet Syndrome

Patients who came for the diagnosis of TOS

Diagnostic Test: Transcutaneous oximetry

Interventions

Transcutaneous oximetry 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.

Patients Suspected of Having Thoracic Outlet Syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, 49933, France

Location

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Interventions

Blood Gas Monitoring, Transcutaneous

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oximetry; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: January 1, 2019
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)