Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection

NCT04369118 | Completed

• 1 other identifier: 38RC19.102
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 3

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 new modality of chest wall restriction is evaluated on patients in post-surgery for lung cancer. The hypothesis is that the use of this medical device would reduce the postoperative pain and increase the efficacy of cough and expectoration. The evolution of the operated patient would be better.

Conditions

Lung Cancer

Keywords

chest wall restriction; usability; lung surgery; medical device; pain; cough; expectoration

Outcome Measures

Primary Outcomes (1)

• Comparison of forced expiratory volume in one second (FEV1) between the two groups.

  Comparisons of forced expiratory volume in one second (FEV1) between the two groups at Day 3. The value of FEV1 is standardized with pre-operative one.

  3 days

Secondary Outcomes (12)

• Comparisons of pulmonary function test between the two groups

  1 month

• Comparisons of Peak expiratory flow at cough between the two groups

  1 month

• Pain evaluation at rest and during cough: ENS scale

  1 month

• Qualification of cough

  10 days

• Characterization of analgesic treatment.

  1 month

Study Arms (2)

Conventional follow-up+chest wall restriction belt

EXPERIMENTAL

Patients in this group benefit from conventional post-operative follow-up and wear the selective chest wall restriction belt in parallel. Patients in this group benefit from conventional post-operative follow-up . From Day 1 to Month 1

Procedure: Conventional follow-up; Device: Conventional follow-up+chest wall restriction belt

conventional postoperative follow-up

ACTIVE COMPARATOR

Patients in this group benefit from conventional post-operative follow-up . From Day 1 to Month 1

Procedure: Conventional follow-up

Interventions

Conventional follow-up PROCEDURE

Patients in this group benefit from conventional post-operative follow-up

Conventional follow-up+chest wall restriction belt; conventional postoperative follow-up

Conventional follow-up+chest wall restriction belt DEVICE

Patients in this group benefit from conventional post-operative follow-up. The patient wear the selective chest wall restriction belt from Day 2 (after surgery) until he ceases to need it.

Conventional follow-up+chest wall restriction belt

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Clinical Investigation Centre for Innovative Technology Network: collaborator

Study Sites (3)

Assistance Publique Hôpitaux de Paris, Hôpital Avicenne

Bobigny, 93000, France

Location

Hôpital Louis Pradel

Bron, 69500, France

Location

CHU Grenoble Alpes

Grenoble, 38043, France

Location

Related Links

• Informations about CIC-IT

MeSH Terms

Conditions

Lung Neoplasms; Pain; Cough

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: April 30, 2020
• Study Start: November 18, 2020
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

FR (3)