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Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome (STOUT)

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ClinicalTrials.gov Identifier: NCT03355274
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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.


Condition or disease Intervention/treatment Phase
Thoracic Outlet Syndrome Diagnostic Test: Transcutaneous Oximetry Not Applicable

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.

For patients, the microcirculation measurement by the TIVI system will be performed on the hands during the operation of the candlestick. The results of any additional examinations and / or pre- and post-operative consultations will be collected.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with thoracic outlet syndrom (patients) Healthy asymptomatic patients (controls)
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Application de l'oxymétrie Dynamique Pour le Diagnostic Des Syndromes de défilés Thoraco-brachiaux Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrom
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: Patients
Patients suspected of thoracic outlet syndrome Transcutaneous oximetry during upper arm manoeuvers
Diagnostic Test: Transcutaneous Oximetry

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

the microcirculation measurement by the tissue vitality (TIVI) system will be performed on the hands during the operation of the candlestick.

Other Name: Tissue vitality system for recording of skin blood flow

Sham Comparator: controls
healthy asymptomatic subjects Transcutaneous oximetry during upper arm manoeuvers
Diagnostic Test: Transcutaneous Oximetry

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

the microcirculation measurement by the tissue vitality (TIVI) system will be performed on the hands during the operation of the candlestick.

Other Name: Tissue vitality system for recording of skin blood flow




Primary Outcome Measures :
  1. Presence of a significant difference of 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 Outcome Measures :
  1. Comparison to angiography in patients [ 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. Analysis of results in controls [ Time Frame: 24 months ]
    o determine the proportion of false positive and false negative results in controls using the cutoff determined in outcome 2



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355274


Contacts
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Contact: Samir MD HENNI, PhD 33(0)241354617 samir.henni@chu-angers.fr
Contact: Pierre MD ABRAHAM, PhD 33(0)241354617 piabraham@chu-angers.fr

Locations
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France
UH Angers Recruiting
Angers, France, 49100
Contact: Samir MD HENNI, PhD    33(0)241354617    samir.henni@chu-angers.fr   
Contact: Pierre MD ABRAHAM, PhD    33(0)241354617    piabraham@chu-angers.fr   
Principal Investigator: Samir MD HENNI, PhD         
Sub-Investigator: Pierre MD ABRAHAM, PhD         
Sub-Investigator: Philippe MD BOUYE         
Sub-Investigator: Marie-Sophie MD FERNANDEZ-LEGRAND         
Sub-Investigator: Valmont MD RICHARD         
Sub-Investigator: Tanguy MD LE MELINIER         
Sub-Investigator: Anne-Sophie MD GOURDIER         
Sub-Investigator: Vincent MD AZZOLA         
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Samir MD HENNI, PhD UH Angers

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03355274     History of Changes
Other Study ID Numbers: 2017-A02554-49
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Angers:
Transcutaneous Oximetry

Additional relevant MeSH terms:
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Syndrome
Thoracic Outlet Syndrome
Disease
Pathologic Processes
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases