Thoracic Outlet SyndromeSTOUTNCT03355274
Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome
A study testing Transcutaneous Oximetry, Photopletysmography and Questionnaires of Quality of Life (QoL) in people with Thoracic Outlet Syndrome, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thoracic Outlet Syndrome
- What is being tested?
- Transcutaneous Oximetry, Photopletysmography and Questionnaires of Quality of Life (QoL)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2018to 4 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- inability to understand the study goal
- Patients protected by decision of law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application de l'oxymétrie Dynamique Pour le Diagnostic Des Syndromes de défilés Thoraco-brachiaux Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrom
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".
Read more
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.
- Conditions
- Thoracic Outlet Syndrome
- Being tested
- Transcutaneous Oximetry, Photopletysmography, Questionnaires of Quality of Life (QoL)
- Keywords
- Transcutaneous Oximetry
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous OximetryDiagnostic test
The examination of transcutaneous Oximetry dynamic measurement with palmar face of both forearms during two consecutive maneuvers known as the "candlestick" (hands up).
PhotopletysmographyDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients suspected of thoracic outlet syndrome Transcutaneous oximetry during upper arm manoeuvers Receives: Diagnostic Test: Transcutaneous Oximetry; Diagnostic Test: Photopletysmography; Other: Questionnaires of Quality of Life (QoL) |
| controls | Sham comparator | healthy asymptomatic subjects Transcutaneous oximetry during upper arm manoeuvers Receives: Diagnostic Test: Transcutaneous Oximetry; Diagnostic Test: Photopletysmography; Other: Questionnaires of Quality of Life (QoL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: inclusion
Secondary outcomes (3)
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.
Measured: 24 months
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
Measured: 24 months
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start26 Mar 2018
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with thoracic outlet syndrom (patients) Healthy asymptomatic patients (controls)
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Samir MD HENNI, PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355274
- Sponsor's protocol ID
- 2017-A02554-49
- Acronym
- STOUT
- Status last verified
- Mar 2025
- First submitted
- 20 Nov 2017
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application de l'oxymétrie Dynamique Pour le Diagnostic Des Syndromes de défilés Thoraco-brachiaux Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrom
- ClinicalTrials.gov ID
- NCT03355274
- Acronym / sponsor ID
- STOUT / 2017-A02554-49
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- Transcutaneous Oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with thoracic outlet syndrom (patients) Healthy asymptomatic patients (controls)
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Diagnostic Test: Transcutaneous Oximetry, Diagnostic Test: Photopletysmography, Other: Questionnaires of Quality of Life (QoL)Patients suspected of thoracic outlet syndrome Transcutaneous oximetry during upper arm manoeuvers |
| controls | Sham comparator | Diagnostic Test: Transcutaneous Oximetry, Diagnostic Test: Photopletysmography, Other: Questionnaires of Quality of Life (QoL)healthy asymptomatic subjects Transcutaneous oximetry during upper arm manoeuvers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy
- inability to understand the study goal
- Patients protected by decision of law
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous OximetryThe examination of transcutaneous Oximetry dynamic measurement with palmar face of both forearms during two consecutive maneuvers known as the "candlestick" (hands up). | Diagnostic test | Patients, controls |
| PhotopletysmographyManeuvers are repeted with the photoplestysmography sensors and in front of a Kinect camera. | Diagnostic test | Patients, controls |
| 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). | Other | Patients, controls |
Primary outcome
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
3 secondary outcomes
Presence of stenosis or occlusion on angiography
Time frame: 24 months
POsitive and negative DROP results
Time frame: 24 months
Angle of appearance of the compression observed on PPG
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 31790665Hersant 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir MD HENNI, PhD principal investigator
UH Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Oximetry, Photopletysmography and Questionnaires of Quality of Life (QoL) in people with Thoracic Outlet Syndrome, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease from Rest of Oxygen Pressure (DROP) during manoeuvers in patients and controls. (time frame: inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03355274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.