Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Application de l'oxymétrie Dynamique Pour le Diagnostic Des Syndromes de défilés Thoraco-brachiaux Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrom

Conditions
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Thoracic Outlet Syndrome

Intervention / Treatment
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* Diagnostic Test: Transcutaneous Oximetry
* Diagnostic Test: Photopletysmography
* Other: Questionnaires of Quality of Life (QoL)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with thoracic outlet syndrom (patients) Healthy asymptomatic patients (controls)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Patients suspected of thoracic outlet syndrome Transcutaneous oximetry during upper arm manoeuvers | Diagnostic Test: Transcutaneous Oximetry<br>* The examination of transcutaneous Oximetry dynamic measurement with palmar face of both forearms during two consecutive maneuvers known as the candlestick (hands up).<br>Diagnostic Test: Photopletysmography<br>* Maneuvers are repeted with the photoplestysmography sensors and in front of a Kinect camera.<br>Other: Questionnaires of Quality of Life (QoL)<br>* Each subject complete 2 QoL questionnaires : Sf-12 (Short Form 12) and DASH (Disabilities of the Arm, Shoulder and Hand).<br>|
| Sham Comparator: controls<br>healthy asymptomatic subjects Transcutaneous oximetry during upper arm manoeuvers | Diagnostic Test: Transcutaneous Oximetry<br>* The examination of transcutaneous Oximetry dynamic measurement with palmar face of both forearms during two consecutive maneuvers known as the candlestick (hands up).<br>Diagnostic Test: Photopletysmography<br>* Maneuvers are repeted with the photoplestysmography sensors and in front of a Kinect camera.<br>Other: Questionnaires of Quality of Life (QoL)<br>* Each subject complete 2 QoL questionnaires : Sf-12 (Short Form 12) and DASH (Disabilities of the Arm, Shoulder and Hand).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease from Rest of Oxygen Pressure (DROP) during manoeuvers in patients and controls. | Difference in DROP observed in the symptomatic arm of patients with suspected thoracic outlet syndrome compared to the dominant arm in controls | inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of stenosis or occlusion on angiography | The performance and cutoff of the DROP will be studied with the AUC (ROC curve) to predict a stenosis on angiography versus no stenosis in patients. | 24 months | 
| POsitive and negative DROP results | To determine the proportion of false positive and false negative results in controls using the cutoff determined in outcome 2 | 24 months | 
| Angle of appearance of the compression observed on PPG | By combining the photopletysmography and a camera Kinect, it is possible to exactly determine the angle of appearance of the compression | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcutaneous Oximetry