Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection
- Conditions
- Lung Cancer
- Interventions
- Procedure: Conventional follow-upDevice: Conventional follow-up+chest wall restriction belt
- Registration Number
- NCT04369118
- Lead Sponsor
- University Hospital, Grenoble
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 94
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional follow-up+chest wall restriction belt Conventional follow-up+chest wall restriction belt 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 Conventional follow-up+chest wall restriction belt Conventional follow-up 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 conventional postoperative follow-up Conventional follow-up Patients in this group benefit from conventional post-operative follow-up . From Day 1 to Month 1
- Primary Outcome Measures
Name Time Method Comparison of forced expiratory volume in one second (FEV1) between the two groups. 3 days 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.
- Secondary Outcome Measures
Name Time Method Comparisons of pulmonary function test between the two groups 1 month Comparisons of pulmonary function test ( forced expiratory volume in one second (FEV1), Forced vital capacity (FVC)) between the two groups. They are expressed as Liters. Before surgery, all days from Day 2 to the patient's exit from hospital (max Day 6) and at the follow-up visit at Month 1. Each value is standardized with pre-operative one.
Pain evaluation at rest and during cough: ENS scale 1 month The patient pain is evaluated using the ENS (Echelle Numérique Standard; standard digital scale, score between 0 to 10) for the two groups. The pain is evaluated all days from Day 2 to the patient's exit from hospital, at the weekly phone follow-up until Month 1 and at the follow-up visit at Month 1.
Characterization of analgesic treatment. 1 month The analgesic drugs are characterized by their class, dose and number of dose taken in the two groups. These elements are evaluated all days from Day 2 to the patient's exit from hospital, at the weekly phone follow-up until Month 1 and at the follow-up visit at Month 1.
Identification of using aerosol therapy, antibiotic therapy and loco-regional anaesthesia 1 month Use of aerosol therapy (yes/no) and class of drugs. Use of antibiotic therapy (yes/no), type of drugs and expected duration of treatment. Use of loco-regional anaesthesia (yes/no), modality of administration and type of drugs. These elements are evaluated all days from Day 2 to the patient's exit from hospital, at the weekly phone follow-up until Month 1 and at the follow-up visit at Month 1.
Comparisons of Peak expiratory flow at cough between the two groups 1 month Comparisons of Peak expiratory flow at cough (PEF) between the two groups. It is expressed as Liters per second. Before surgery, all days from Day 2 to Day 6 and at the follow-up visit at Month 1. Each value is standardized with pre-operative one.
Number and classification of post-surgery complications 1 month Number and classification of post-surgery complications.For the two groups from Day 1 to the follow-up visit at Month 1.
The length of hospital stay 10 days The length of hospital stay in days for the two groups.
Evaluation of medical device usability for patient 1 month Only for the medical device's group.
1. Qualitative questionnaire specifically created about efficacy and acceptability of the medical device at the patient 's exit from hospital. This questionnaire uses Likert scale from 0 to 10 to evaluate each use step of the medical device, closed-ended questions and open questions for comments. A descriptive analysis will done with the answers
2. Closed-ended questions will be asked in a questionnaire specifically created about acceptability and use of the medical device. A descriptive analysis will done with the answers and will be asked during the weekly phone follow-up.Evaluation of medical device usability for caregivers 1 month Only for the medical device's group. This questionnaire uses Likert scales from 0 to 10 to evaluate each use step ofthe medical device, closed-ended questions and open questions fr comments. It will be asked at the end of the clinical study at each caregiver.
Qualification of cough 10 days The cough is classified with this scale : 0-dry cough; 1-productive cough without expectoration; 2-productive cough with expectoration; 3-productive cough with important and/or difficult expectoration. It's qualified for the two groups all days from Day 2 to the patient's exit from hospital.
Quantification of the quality of life evaluated with the EQ-5D-5L questionnaire 1 month The EQ-5D is a generic preference-based measure that indirectly measures the utility for health that generates an index-based summary score based upon societal preference weights. The EQ-5D-5L consists of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale (VAS) for health status. Each item has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity). The VAS ranges from 0 (worst health status) and 100 (best health status). Comparison between the two groups preoperatively, at the patient's exit from hospital, at Day 15 during the phone follow-up and at the follow-up visit at Month 1.
Consumption of hospital care 1 month Comparions of the number of the consumption of hospital care (medical acts and consultations, rehospitalization) between the two groups from Day 1 to the follow-up visit at Month 1.
Trial Locations
- Locations (3)
Assistance Publique Hôpitaux de Paris, Hôpital Avicenne
🇫🇷Bobigny, France
Hôpital Louis Pradel
🇫🇷Bron, France
CHU Grenoble Alpes
🇫🇷Grenoble, France