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CompletedNCT03355274STOUTUpdated Mar 17, 2025

Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome

An interventional study of Transcutaneous Oximetry and Photopletysmography in Thoracic Outlet Syndrome, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Diagnostic

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Phase
Not applicable
Study type
Interventional
Enrollment
222
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Thoracic Outlet Syndrome with a site in France — 3 open to participants now, 3 under way, none of them phase 3. Thoracic Outlet Syndrome · France.

Started
2018
with 2 others
No phase
3 of 10
none open now
Registered
1st of 10
by date
Lead sponsor
6 of 10
University Hospital, Angers

Among the 10 studies in Thoracic Outlet Syndrome with a site in France, this one is one of 3 that started in 2018, is one of 3 with no phase, and was the 1st registered.

Thoracic Outlet Syndrome

33 studies on the registry are indexed under Thoracic Outlet Syndrome; 11 are open to participants now.

Browse Thoracic Outlet Syndrome studies →

Open to participants now

3 of the 10 studies in Thoracic Outlet Syndrome with a site in France are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 8 Thoracic Outlet Syndrome studies recruiting now, 4 set no upper age limit and 3 stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Thoracic Outlet Syndrome

Keywords

  • Transcutaneous Oximetry
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • pregnancy
  • inability to understand the study goal
  • Patients protected by decision of law
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
222 participants (actual)

Study arms

  • Experimental
    Patients

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

    Diagnostic Test: Transcutaneous Oximetry · Diagnostic Test: Photopletysmography · Other: Questionnaires of Quality of Life (QoL)

  • Sham comparator
    controls

    healthy asymptomatic subjects Transcutaneous oximetry during upper arm manoeuvers

    Diagnostic Test: Transcutaneous Oximetry · Diagnostic Test: Photopletysmography · Other: Questionnaires of Quality of Life (QoL)

Interventions

  • Diagnostic testTranscutaneous Oximetry

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

  • Diagnostic testPhotopletysmography

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

  • OtherQuestionnaires 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).

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: inclusion

Secondary outcomes

  1. 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.

    Time frame: 24 months

  2. 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

    Time frame: 24 months

  3. 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

    Time frame: 24 months

07

Study locations

1 site
  • UH Angers
    Angers, 49100, France
08

References and documents

Publications

  • 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. PubMed 31790665 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Jan 2024, 69 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2017
First posted
Nov 28, 2017
StartActual
Mar 26, 2018
Primary completionActual
Jan 4, 2024
CompletionActual
Jan 4, 2024
Last update
Mar 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03355274
Responsible party
Sponsor
First posted
Nov 28, 2017
Start date
Mar 26, 2018
Primary completion
Jan 4, 2024
Completion
Jan 4, 2024
Last update
Mar 17, 2025

Study contacts

Samir MD HENNI, PhD
principal investigator · UH Angers

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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