Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome

Thoracic Outlet Syndrome Clinical Trial

— STOUT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03355274
• Other study ID #: 2017-A02554-49
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 222
• Est. completion date: March 26, 2023
• Est. primary completion date: March 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Thoracic Outlet Syndrome

Intervention

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).
• 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).

Locations

Country	Name	City	State
France	UH Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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