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CompletedNCT05702866Updated Jan 27, 2023

Vascular Compression Assessment Using Transcutaneous Oxymetry in Patients Suspected of Having Thoracic Outlet Syndrome

An observational study in Thoracic Outlet Syndrome, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-27.

Sponsored by University Hospital, Angers · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

Thoracic outlet syndrome (TOS) is characterized by nervous, venous or arterial symptoms resulting from a compression of the thoracic bundle in the thoracic outlet. The diagnostic approach of TOS is still controversial. The investigating team is interested in arterial TOS and have already been able to demonstrate the presence of arm ischemia during dynamic maneuvers using transcutaneous oximetry (TcpO2). The correlation between the measurement of TcpO2 during dynamic maneuvers and the vascular compression type (arterial, venous or both) will be evaluated. The evaluation the correlation between TcpO2 and degree of arterial compression observed in dynamic arteriography (considered as a gold standard examination) will be calculated too. The use of TcpO2 could be developed in the diagnosis assessment of TOS.

02

Conditions studied

  • Thoracic Outlet Syndrome

Keywords

  • transcutaneous oximetry
  • thoracic outlet syndrome
  • arteriography
  • vascular compression
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In context

Thoracic Outlet Syndrome

33 studies on the registry are indexed under Thoracic Outlet Syndrome; 12 are open to participants now.

This study's enrollment of 200 is above the median of 84 across 16 observational studies indexed under Thoracic Outlet Syndrome.

Browse Thoracic Outlet Syndrome studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient presenting to the vascular medicine department with suspected thoracic outlet syndrome.

Inclusion criteria

  • patient suspected of having a thoracic outlet syndrome
  • patient having carried out additional examinations as part of the diagnostic assessment : venous and arterial Doppler or dynamic arteriography and venography
  • patient having carried out a dynamic TcpO2 recording

Exclusion criteria

Exclusion Criteria:

  • patient under 18 year old
  • non french speaker
  • patient who expressed his/her refusal
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients Suspected of Having Thoracic Outlet Syndrome

    Patients who came for the diagnosis of TOS

    Diagnostic Test: Transcutaneous oximetry

Interventions

  • Diagnostic testTranscutaneous oximetry

    Comparison of the TcpO2 values recorded during dynamic maneuver with the estimated rate of compression of the subclavian and axillary vessels determined on dynamic angiography.

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What researchers measure

Primary outcomes

  1. DROPmin according on the type of compression

    Variation in upper limb ischemia is estimated by TcpO2 measurement and calculating of the DROPmin (TcpO2 variation regarding a reference) depending on the type of damage (arterial, venous, or both arterial and venous). DROP is Decrease Rest of Oxygen Pressure

    Time frame: thirty minutes

Secondary outcomes

  1. DROPmin according on the degree of arterial stenosis

    To assess the correlation between the severity of upper limb ischemia by TcpO2 measurement and the degree of arterial stenosis observed in diagnostic arteriography.

    Time frame: thirty minutes

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Study locations

1 site
  • CHU Angers
    Angers, 49933, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05702866
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Jan 27, 2023
Start date
Jan 1, 2019
Primary completion
Oct 30, 2022
Completion
Oct 30, 2022
Last update
Jan 27, 2023

Oversight

Data monitoring committee
No
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 Jan 2023. You cannot join it, but the record below documents what was studied.

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