Skip to main content
OpenTrials
Completed

NCT Number: NCT05702866

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thoracic Outlet Syndrome Cardiovascular Diseases Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers

Angers, 49933, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2023
Registry last updated
Jan 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.