Clinical Routine in Thoracic Outlet Syndrome

NCT04376177 | Unknown

• 1 other identifier: 2020/17
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thoracic Outlet Syndrome

Outcome Measures

Primary Outcomes (1)

• ultrasound

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

  1 hour

Other Outcomes (4)

• angiography encoding

  1 week

• Questionnaire scoring

  1 hour

• Transcutaneous oximetry

  1 hour

Study Arms (1)

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; Diagnostic Test: angiography; Diagnostic Test: questionnaires; Diagnostic Test: Transcutaneous oximetry; Diagnostic Test: plethysmography; Diagnostic Test: Electromyogram; Diagnostic Test: Standard X-Ray

Interventions

Ultrasound DIAGNOSTIC_TEST

Echodoppler imaging of upper limbs performed by trained operators at rest and during provocative maneuvers for TOS diagnosis.

Patients with Thoracic outlet syndrome

angiography DIAGNOSTIC_TEST

Angiography (arterial and/or venous) of upper limbs performed by trained operators at rest and during provocative maneuvers such for TOS diagnosis.

Patients with Thoracic outlet syndrome

questionnaires DIAGNOSTIC_TEST

Use of standard questionnaires (MASC, DASH, SF36) for the evaluation of upper limb symptoms self-completed by the patients at admission.

Patients with Thoracic outlet syndrome

Transcutaneous oximetry DIAGNOSTIC_TEST

Mesurement of transcutaneuos oxygen pressure on both forearms performed at rest and during provocative maneuversfor TOS diagnosis.

Patients with Thoracic outlet syndrome

plethysmography DIAGNOSTIC_TEST

Photoplethysmography of the forearms or fingers performed at rest and during provocative maneuvers for TOS diagnosis

Patients with Thoracic outlet syndrome

Electromyogram DIAGNOSTIC_TEST

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

Patients with Thoracic outlet syndrome

Standard X-Ray DIAGNOSTIC_TEST

Standard X-Ray performed for the research of apophysomegaly or additionnal cervical rib.

Patients with Thoracic outlet syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University Hospital

Angers, 49933, France

RECRUITING

Related Publications (2)

• Hersant J, Lecoq S, Ramondou P, Feuilloy M, Abraham P, Henni S. Upper arm versus forearm transcutaneous oximetry during upper limb abduction in patients with suspected thoracic outlet syndrome. Front Physiol. 2022 Nov 8;13:1033137. doi: 10.3389/fphys.2022.1033137. eCollection 2022.

  PMID: 36425296 DERIVED

• Hersant J, Ramondou P, Josse C, Lecoq S, Henni S, Abraham P. Quantitative analysis of venous outflow with photo-plethysmography in patients with suspected thoracic outlet syndrome. Front Cardiovasc Med. 2022 Oct 28;9:803919. doi: 10.3389/fcvm.2022.803919. eCollection 2022.

  PMID: 36386307 DERIVED

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Interventions

Ultrasonography; Angiography; Blood Gas Monitoring, Transcutaneous; Plethysmography; Electromyography

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Diagnostic Techniques, Cardiovascular; Oximetry; Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Heart Function Tests; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques; Electrodiagnosis; Myography

Study Officials

• Pierre ABRAHAM, MD; PhD

  University and univerity hospital in Angers, FRANCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

pierre Abraham, MD PhD

CONTACT

+33241353689; piabraham@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2020
• First Posted: May 6, 2020
• Study Start: January 1, 2018
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 3, 2021

Record last verified: 2021-06

Locations

FR (1)