Clinical trial NCT04369118: Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection
Official title: Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection. A Multicenter, Prospective, Controlled, Randomized Study With Stratification on the Surgical Approach, Open With a Blind Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: chest wall restriction
usability
lung surgery
medical device
pain
cough
expectoration
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
First posted: 2020-04-30
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 2 groups: a control group of patients with conventional follow-up and an experimental group of patients with conventional follow-up and a daily wear of the selective chest wall restriction belt after surgery.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of forced expiratory volume in one second (FEV1) between the two groups.
timeFrame: 3 days
Secondary outcomes:
measure: Comparisons of pulmonary function test between the two groups
timeFrame: 1 month
measure: Comparisons of Peak expiratory flow at cough between the two groups
timeFrame: 1 month
measure: Pain evaluation at rest and during cough: ENS scale
timeFrame: 1 month
measure: Qualification of cough
timeFrame: 10 days
measure: Characterization of analgesic treatment.
timeFrame: 1 month
measure: Identification of using aerosol therapy, antibiotic therapy and loco-regional anaesthesia
timeFrame: 1 month
measure: Number and classification of post-surgery complications
timeFrame: 1 month
measure: The length of hospital stay
timeFrame: 10 days
measure: Quantification of the quality of life evaluated with the EQ-5D-5L questionnaire
timeFrame: 1 month
measure: Consumption of hospital care
timeFrame: 1 month
measure: Evaluation of medical device usability for patient
timeFrame: 1 month
measure: Evaluation of medical device usability for caregivers
timeFrame: 1 month
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Assistance Publique Hôpitaux de Paris, Hôpital Avicenne
city: Bron
country: France
facility: Hôpital Louis Pradel
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
References: