Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome
- Conditions
- Thoracic Outlet Syndrome
- Interventions
- Diagnostic Test: Transcutaneous OximetryDiagnostic Test: PhotopletysmographyOther: Questionnaires of Quality of Life (QoL)
- Registration Number
- NCT03355274
- Lead Sponsor
- University Hospital, Angers
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
- 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
- pregnancy
- inability to understand the study goal
- Patients protected by decision of law
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients Transcutaneous Oximetry Patients suspected of thoracic outlet syndrome Transcutaneous oximetry during upper arm manoeuvers Patients Questionnaires of Quality of Life (QoL) Patients suspected of thoracic outlet syndrome Transcutaneous oximetry during upper arm manoeuvers controls Questionnaires of Quality of Life (QoL) healthy asymptomatic subjects Transcutaneous oximetry during upper arm manoeuvers Patients Photopletysmography Patients suspected of thoracic outlet syndrome Transcutaneous oximetry during upper arm manoeuvers controls Transcutaneous Oximetry healthy asymptomatic subjects Transcutaneous oximetry during upper arm manoeuvers controls Photopletysmography healthy asymptomatic subjects Transcutaneous oximetry during upper arm manoeuvers
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
Trial Locations
- Locations (1)
UH Angers
🇫🇷Angers, France