Status:
COMPLETED
Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Clinical Investigation Centre for Innovative Technology Network
Conditions:
Lung Cancer
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the efficacy of a new medical device in post-surgery of lung resection. The principle of this new device is based on selective chest wall restriction. This n...
Detailed Description
The present study is the first evaluation of the efficacy of a selective chest wall restriction belt. The efficacy will be estimate on forced expiratory volume in one second (FEV1) at D3 by comparing...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Patients with segmentectomy or lobectomy for lung cancer or lung cancer suspicious,
- Surgical approach : video-assisted thoracic surgery (VATS) or thoracotomy,
- Patients affiliated to social security or similarly regime,
- Patients who gave their consent to participate in the study.
- Exclusion Criteria :
- Patients with outcomes of the pulmonary function test at the preoperative assessment : forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) \> 45% predicted post-operative values and VO2max (maximal oxygen consumption) between 10 and 12 ml/kg/min,
- Patients with a waist size \> 120 cm
- Patients with medical treatment for chronic pain (neuropathic pain,…)
- Patients with tuberculosis or other pulmonary infectious pathology proven (aspergillosis, lung abscess, actinomycosis,…),
- Patients carrying a resistant germs or extended-spectrum beta-lactamase (ESBL),
- Paraplegic patients
- Patients with a diagnosed, progressive and/or uncontrolled neurological disease
- Patients with a progressive psychosis or a serious psychotic history (hospitalization)
- Patients who are in exclusion period of another interventional study
- Protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
Exclusion
Key Trial Info
Start Date :
November 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04369118
Start Date
November 18 2020
End Date
February 29 2024
Last Update
May 17 2024
Active Locations (3)
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1
Assistance Publique Hôpitaux de Paris, Hôpital Avicenne
Bobigny, France, 93000
2
Hôpital Louis Pradel
Bron, France, 69500
3
CHU Grenoble Alpes
Grenoble, France, 38043