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

Completed

• Conditions: Thoracic Outlet Syndrome
• Interventions: Diagnostic Test: Transcutaneous oximetry

• Registration Number: NCT05702866
• Lead Sponsor: University Hospital, Angers

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Status Verified: 2023-01
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-26
• Last Update Submitted: 2023-01-26
• Study First Posted: 2023-01-27
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Suspected of Having Thoracic Outlet Syndrome	Transcutaneous oximetry	Patients who came for the diagnosis of TOS

Primary Outcome Measures

Name	Time	Method
DROPmin according on the type of compression	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

Secondary Outcome Measures

Name	Time	Method
DROPmin according on the degree of arterial stenosis	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.

Trial Locations

Locations (1)

CHU Angers; 🇫🇷 Angers, France