Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03355274 |
Other study ID # |
2017-A02554-49 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 26, 2018 |
Est. completion date |
March 26, 2023 |
Study information
Verified date |
September 2022 |
Source |
University Hospital, Angers |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.