Clinical Routine in Thoracic Outlet Syndrome (SKIPA)

June 2, 2021 updated by: University Hospital, Angers

Evaluation Des Mesures Dopplers, Angiographiques, Radiographique Oximetriques, Plethysmographiques, Electromyographiques et Des Questionnaires Cliniques Des Patients adressés Pour Suspicion de Syndrome du défilé Thoraco-brachial

Transversal recording and analysis of investigations performed in patients referred for suspected thoracic outlet syndrome (TOS)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will have recording on a database of all investigations that were eventually performed for the diagnosis or follow up of their disease, among which:

  • Characteristics (Age, Gender height, weight, ongoing treatment ,
  • professional activity, sports activity,
  • Symptoms.
  • Forearm and finger photoplethysmography (PPG) during provocative maneuvers of the upper limb
  • Transcutaneous oxymetry (Tcpo2) recording
  • Standard questionnaires (MASC, DASH, FS36)
  • Doppler and ultrasound during provocative maneuvers of the upper limb
  • Angiography during provocative maneuvers of the upper limb
  • Electromyogram
  • Standard X-ray

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France, 49933
        • Recruiting
        • University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult subjects referred for the diagnosis or follow up of TOS

Description

Inclusion Criteria:

  • Absence of deny for the use of medical filesfor research purposes

Exclusion Criteria:

  • Inability to understand the purpose of the database.
  • Patient protected by law.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Thoracic outlet syndrome
Patients referred to the University Hospital of Angers for the diagnostis or follow-up of thoracic outlet syndrome
Diagnostic test: Ultrasound
Echodoppler imaging of upper limbs performed by trained operators at rest and during provocative maneuvers for TOS diagnosis.
Diagnostic test: angiography
Angiography (arterial and/or venous) of upper limbs performed by trained operators at rest and during provocative maneuvers such for TOS diagnosis.
Diagnostic test: questionnaires
Use of standard questionnaires (MASC, DASH, SF36) for the evaluation of upper limb symptoms self-completed by the patients at admission.
Diagnostic test: Transcutaneous oximetry
Mesurement of transcutaneuos oxygen pressure on both forearms performed at rest and during provocative maneuversfor TOS diagnosis.
Diagnostic test: plethysmography
Photoplethysmography of the forearms or fingers performed at rest and during provocative maneuvers for TOS diagnosis
Diagnostic test: Electromyogram
Electromyography of the upper limbs with encoding of the physician for the presence or abnsence of signs of plexis compression (impairment of the response on C8 T1 erea
Diagnostic test: Standard X-Ray
Standard X-Ray performed for the research of apophysomegaly or additionnal cervical rib.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ultrasound
Time Frame: 1 hour
Retrieval of ultrasound interpretation as recorded in the patients' file by the physician that performed the test
1 hour

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
angiography encoding
Time Frame: 1 week
Retrieval of angiography interpretation as recorded in the patients' file by the physician that performed the test
1 week
Questionnaire scoring
Time Frame: 1 hour
Scoring of the questionnaires according to their respective scoring methods
1 hour
Transcutaneous oximetry
Time Frame: 1 hour
Recording of the decrease from rest of oxygen pressure (DROP) minimal value observed during the provocative maneuvers
1 hour
Plethysmography interpretation
Time Frame: 1 hour
Analysis of the pattern of volume changes observed during provocative maneuvers
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Pierre ABRAHAM, MD; PhD, University and univerity hospital in Angers, FRANCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

May 2, 2020

First Submitted That Met QC Criteria

May 2, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

June 3, 2021

Last Update Submitted That Met QC Criteria

June 2, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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