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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 6
- 主要终点
- Comparison of forced expiratory volume in one second (FEV1) between the two groups.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Comparison of forced expiratory volume in one second (FEV1) between the two groups.
时间窗: 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.
次要结局
- Comparisons of pulmonary function test between the two groups(1 month)
- Pain evaluation at rest and during cough: ENS scale(1 month)
- Characterization of analgesic treatment.(1 month)
- Identification of using aerosol therapy, antibiotic therapy and loco-regional anaesthesia(1 month)
- Comparisons of Peak expiratory flow at cough between the two groups(1 month)
- Number and classification of post-surgery complications(1 month)
- The length of hospital stay(10 days)
- Evaluation of medical device usability for patient(1 month)
- Evaluation of medical device usability for caregivers(1 month)
- Qualification of cough(10 days)
- Quantification of the quality of life evaluated with the EQ-5D-5L questionnaire(1 month)
- Consumption of hospital care(1 month)