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Completed

NCT Number: NCT03355274

Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome

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.

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Key information

Conditions

Thoracic Outlet Syndrome Cardiovascular Diseases Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Angers

Angers, 49100, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous oximetry

Diagnostic Test

The examination of transcutaneous Oximetry dynamic measurement with palmar face of both forearms during two consecutive maneuvers known as the "candlestick" (hands up).

Photopletysmography

Diagnostic Test

Maneuvers are repeted with the photoplestysmography sensors and in front of a Kinect camera.

Questionnaires of Quality of Life (QoL)

Other

Each subject complete 2 QoL questionnaires : Sf-12 (Short Form 12) and DASH (Disabilities of the Arm, Shoulder and Hand).

Primary outcomes

  1. Decrease from Rest of Oxygen Pressure (DROP) during manoeuvers in patients and controls.

    Time frame: inclusion

    Difference in DROP observed in the symptomatic arm of patients with suspected thoracic outlet syndrome compared to the dominant arm in controls

Secondary outcomes

  1. Presence of stenosis or occlusion on angiography

    Time frame: 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.

  2. POsitive and negative DROP results

    Time frame: 24 months

    To determine the proportion of false positive and false negative results in controls using the cutoff determined in outcome 2

  3. Angle of appearance of the compression observed on PPG

    Time frame: 24 months

    By combining the photopletysmography and a camera Kinect, it is possible to exactly determine the angle of appearance of the compression

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: STOUT

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 28, 2017
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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