SKIPA: Clinical Routine in Thoracic Outlet Syndrome

Sponsor
University Hospital, Angers (Other)
Overall Status
Recruiting
CT.gov ID
NCT04376177
Collaborator
(none)
1,000
1
95
10.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasound
  • Diagnostic Test: angiography
  • Diagnostic Test: questionnaires
  • Diagnostic Test: Transcutaneous oximetry
  • Diagnostic Test: plethysmography
  • Diagnostic Test: Electromyogram
  • Diagnostic Test: Standard X-Ray

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Evaluation Des Mesures Dopplers, Angiographiques, Radiographique Oximetriques, Plethysmographiques, Electromyographiques et Des Questionnaires Cliniques Des Patients adressés Pour Suspicion de Syndrome du défilé Thoraco-brachial
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. ultrasound [1 hour]

    Retrieval of ultrasound interpretation as recorded in the patients' file by the physician that performed the test

Other Outcome Measures

  1. angiography encoding [1 week]

    Retrieval of angiography interpretation as recorded in the patients' file by the physician that performed the test

  2. Questionnaire scoring [1 hour]

    Scoring of the questionnaires according to their respective scoring methods

  3. Transcutaneous oximetry [1 hour]

    Recording of the decrease from rest of oxygen pressure (DROP) minimal value observed during the provocative maneuvers

  4. Plethysmography interpretation [1 hour]

    Analysis of the pattern of volume changes observed during provocative maneuvers

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Angers France 49933

Sponsors and Collaborators

  • University Hospital, Angers

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT04376177
Other Study ID Numbers:
  • 2020/17
First Posted:
May 6, 2020
Last Update Posted:
Jun 3, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2021