Systematic Transcutaneous Oxymetry Use in Thoracic Outlet Syndrome

NCT03355274 | Completed DMC

• 1 other identifier: 2017-A02554-49
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Outlet Syndrome

Keywords

Transcutaneous Oximetry

Outcome Measures

Primary Outcomes (1)

• Decrease from Rest of Oxygen Pressure (DROP) during manoeuvers in patients and controls.

  Difference in DROP observed in the symptomatic arm of patients with suspected thoracic outlet syndrome compared to the dominant arm in controls

  inclusion

Secondary Outcomes (3)

• Presence of stenosis or occlusion on angiography

  24 months

• POsitive and negative DROP results

  24 months

• Angle of appearance of the compression observed on PPG

  24 months

Study Arms (2)

Patients

EXPERIMENTAL

Patients suspected of thoracic outlet syndrome Transcutaneous oximetry during upper arm manoeuvers

Diagnostic Test: Transcutaneous Oximetry; Diagnostic Test: Photopletysmography; Other: Questionnaires of Quality of Life (QoL)

controls

SHAM COMPARATOR

healthy asymptomatic subjects Transcutaneous oximetry during upper arm manoeuvers

Diagnostic Test: Transcutaneous Oximetry; Diagnostic Test: Photopletysmography; Other: Questionnaires of Quality of Life (QoL)

Interventions

Transcutaneous Oximetry DIAGNOSTIC_TEST

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

Patients; controls

Photopletysmography DIAGNOSTIC_TEST

Maneuvers are repeted with the photoplestysmography sensors and in front of a Kinect camera.

Patients; controls

Questionnaires of Quality of Life (QoL) OTHER

Each subject complete 2 QoL questionnaires : Sf-12 (Short Form 12) and DASH (Disabilities of the Arm, Shoulder and Hand).

Patients; controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnancy
• inability to understand the study goal
• Patients protected by decision of law

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

UH Angers

Angers, 49100, France

Location

Related Publications (1)

• Hersant J, Ramondou P, Guilleron C, Picquet J, Henni S, Abraham P. A pilot study of forearm microvascular impairment and pain while using a telephone. Microvasc Res. 2020 May;129:103963. doi: 10.1016/j.mvr.2019.103963. Epub 2019 Nov 29.

  PMID: 31790665 DERIVED

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Interventions

Blood Gas Monitoring, Transcutaneous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Samir MD HENNI, PhD

  UH Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Patients with thoracic outlet syndrom (patients) Healthy asymptomatic patients (controls)

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 28, 2017
• Study Start: March 26, 2018
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

FR (1)