Clinical trial NCT03355274: Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome
Official title: Application de l'oxymétrie Dynamique Pour le Diagnostic Des Syndromes de défilés Thoraco-brachiaux Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Outlet Syndrome
Keywords: Transcutaneous Oximetry
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2017-11-28
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with thoracic outlet syndrom (patients) Healthy asymptomatic patients (controls)
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decrease from Rest of Oxygen Pressure (DROP) during manoeuvers in patients and controls.
timeFrame: inclusion
Secondary outcomes:
measure: Presence of stenosis or occlusion on angiography
timeFrame: 24 months
measure: POsitive and negative DROP results
timeFrame: 24 months
measure: Angle of appearance of the compression observed on PPG
timeFrame: 24 months
Other outcomes:
Locations:
city: Angers
country: France
facility: UH Angers
Study officials:
affiliation: UH Angers
name: Samir MD HENNI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hersant J, Ramondou P, Guilleron C, Picquet J, Henni S, Abraham P. A pilot study of forearm microvascular impairment and pain while using a telephone. Microvasc Res. 2020 May;129:103963. doi: 10.1016/j.mvr.2019.103963. Epub 2019 Nov 29.