Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome (STOUT)

University Hospital, Angers

Status: Completed

Conditions: Thoracic Outlet Syndrome

Treatments: Diagnostic Test: Transcutaneous Oximetry; Other: Questionnaires of Quality of Life (QoL); Diagnostic Test: Photopletysmography

Study type: Interventional

Funder types: Other

Identifiers

NCT03355274

2017-A02554-49

Details and patient eligibility

About

The measurement of the transcutaneous oxygen partial pressure (TCPO2) at exercise is, to our knowledge, the only method to estimate during the exercise the importance of ischemia segment of limb by segment of limb bilaterally and carry on. The diagnosis of thoracic outlet syndrome causing remains difficult and dependent operator in ultrasound because of the risk of false positive (loss of signal) or false negative (insufficient effort, inappropriate movement).

Our main hypothesis is the existence of significant measurable ischemia in the forearm by transcutaneous oximetry during the maneuvering of the "candlestick".

In the event of failure of this maneuver, the other maneuvers such as those of Wright, Roos, Tinel and Adson will be realized.

In this study we want to evaluate the possibility of using dynamic transcutaneous Oximetry as a tool for evaluating ischemia in case of suspicion of thoracic outlet syndrome causing.

Full description

Patients referred for suspected thoracic outlet syndrome causing and healthy asymptomatic subjects will be included.

After signing the consent, the subject will have a clinical and paraclinical examination. Age, sex, height, weight, side of clinical symptomatology will be collected. Medical history current treatments will also be noted.

The examination of transcutaneous oximetry dynamic measurement with palmar face of both forearms during two consecutive maneuvers known as the "candlestick" (hands up). The most symptomatic arm value in patients and the dominant arm in the control group will be noted. In case of DROP between 0 and -25 mmHg, in addition to the maneuvering of the "candlestick", the other maneuvers such as those of Wright, Roos, Tinel and Adson will be realized.

The results of any additional examinations and / or pre- and post-operative consultations will be collected.

Subjects complete two Quality of Life questionnaires: the SF-12 (Short Form 12) and the DASH questionnaire (Disabilities of the Arm, Shoulder and Hand).

Added by an amendment : Photoplethysmography has already done its proofs to determine the thoracic outlet syndrome diagnotic. Combine with a camera Kinect, they should determine the angle of appearance of compression in the 3 dimensions of space.

Enrollment: 222 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• subjects referred for investigation of thoracic outlet syndrome causing
• Affiliation to the French National healthcare system
• French speaking patients
• Ability to stand still for half a minute

Exclusion criteria

• pregnancy
• inability to understand the study goal
• Patients protected by decision of law

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

Patients

Experimental group

Description:

Patients suspected of thoracic outlet syndrome Transcutaneous oximetry during upper arm manoeuvers

Treatment:

Diagnostic Test: Photopletysmography

Other: Questionnaires of Quality of Life (QoL)

Diagnostic Test: Transcutaneous Oximetry

controls

Sham Comparator group

Description:

healthy asymptomatic subjects Transcutaneous oximetry during upper arm manoeuvers

Treatment:

Diagnostic Test: Photopletysmography

Other: Questionnaires of Quality of Life (QoL)

Diagnostic Test: Transcutaneous Oximetry