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Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome (STOUT)

Primary Purpose

Thoracic Outlet Syndrome

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcutaneous Oximetry
Photopletysmography
Questionnaires of Quality of Life (QoL)
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Thoracic Outlet Syndrome focused on measuring Transcutaneous Oximetry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UH Angers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Patients

controls

Arm Description

Patients suspected of thoracic outlet syndrome Transcutaneous oximetry during upper arm manoeuvers

healthy asymptomatic subjects Transcutaneous oximetry during upper arm manoeuvers

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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

Full Information

First Posted
November 20, 2017
Last Updated
September 26, 2022
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT03355274
Brief Title
Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
March 26, 2023 (Anticipated)
Study Completion Date
March 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Outlet Syndrome
Keywords
Transcutaneous Oximetry

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients with thoracic outlet syndrom (patients) Healthy asymptomatic patients (controls)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients suspected of thoracic outlet syndrome Transcutaneous oximetry during upper arm manoeuvers
Arm Title
controls
Arm Type
Sham Comparator
Arm Description
healthy asymptomatic subjects Transcutaneous oximetry during upper arm manoeuvers
Intervention Type
Diagnostic Test
Intervention Name(s)
Transcutaneous Oximetry
Intervention Description
The examination of transcutaneous Oximetry dynamic measurement with palmar face of both forearms during two consecutive maneuvers known as the "candlestick" (hands up).
Intervention Type
Diagnostic Test
Intervention Name(s)
Photopletysmography
Intervention Description
Maneuvers are repeted with the photoplestysmography sensors and in front of a Kinect camera.
Intervention Type
Other
Intervention Name(s)
Questionnaires of Quality of Life (QoL)
Intervention Description
Each subject complete 2 QoL questionnaires : Sf-12 (Short Form 12) and DASH (Disabilities of the Arm, Shoulder and Hand).
Primary Outcome Measure Information:
Title
Decrease from Rest of Oxygen Pressure (DROP) during manoeuvers in patients and controls.
Description
Difference in DROP observed in the symptomatic arm of patients with suspected thoracic outlet syndrome compared to the dominant arm in controls
Time Frame
inclusion
Secondary Outcome Measure Information:
Title
Presence of stenosis or occlusion on angiography
Description
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.
Time Frame
24 months
Title
POsitive and negative DROP results
Description
To determine the proportion of false positive and false negative results in controls using the cutoff determined in outcome 2
Time Frame
24 months
Title
Angle of appearance of the compression observed on PPG
Description
By combining the photopletysmography and a camera Kinect, it is possible to exactly determine the angle of appearance of the compression
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir MD HENNI, PhD
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Angers
City
Angers
ZIP/Postal Code
49100
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31790665
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.
Results Reference
derived

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Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome

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