STOUT: Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients Patients suspected of thoracic outlet syndrome Transcutaneous oximetry during upper arm manoeuvers |
Diagnostic Test: Transcutaneous Oximetry
The examination of transcutaneous Oximetry dynamic measurement with palmar face of both forearms during two consecutive maneuvers known as the "candlestick" (hands up).
Diagnostic Test: Photopletysmography
Maneuvers are repeted with the photoplestysmography sensors and in front of a Kinect camera.
Other: Questionnaires of Quality of Life (QoL)
Each subject complete 2 QoL questionnaires : Sf-12 (Short Form 12) and DASH (Disabilities of the Arm, Shoulder and Hand).
|
| Sham Comparator: controls healthy asymptomatic subjects Transcutaneous oximetry during upper arm manoeuvers |
Diagnostic Test: Transcutaneous Oximetry
The examination of transcutaneous Oximetry dynamic measurement with palmar face of both forearms during two consecutive maneuvers known as the "candlestick" (hands up).
Diagnostic Test: Photopletysmography
Maneuvers are repeted with the photoplestysmography sensors and in front of a Kinect camera.
Other: Questionnaires of Quality of Life (QoL)
Each subject complete 2 QoL questionnaires : Sf-12 (Short Form 12) and DASH (Disabilities of the Arm, Shoulder and Hand).
|
Outcome Measures
Primary Outcome Measures
- Decrease from Rest of Oxygen Pressure (DROP) during manoeuvers in patients and controls. [inclusion]
Difference in DROP observed in the symptomatic arm of patients with suspected thoracic outlet syndrome compared to the dominant arm in controls
Secondary Outcome Measures
- Presence of stenosis or occlusion on angiography [24 months]
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.
- POsitive and negative DROP results [24 months]
To determine the proportion of false positive and false negative results in controls using the cutoff determined in outcome 2
- Angle of appearance of the compression observed on PPG [24 months]
By combining the photopletysmography and a camera Kinect, it is possible to exactly determine the angle of appearance of the compression
Eligibility Criteria
Criteria
Inclusion Criteria:
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subjects referred for investigation of thoracic outlet syndrome causing
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Affiliation to the French National healthcare system
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French speaking patients
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Ability to stand still for half a minute
Exclusion Criteria:
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pregnancy
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inability to understand the study goal
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Patients protected by decision of law
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UH Angers | Angers | France | 49100 |
Sponsors and Collaborators
- University Hospital, Angers
Investigators
- Principal Investigator: Samir MD HENNI, PhD, UH Angers
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-A02554-49