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临床试验/NCT03010033
NCT03010033Unknown不适用

Effects of Pulmonary Rehabilitation and Airway Management on Short-term and Long-term Perioperative Results of Lobectomy in Smoker Patients With Lung Cancer

Ruijin Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年1月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
postoperative pulmonary complications

研究概览

简要总结

It is reported that smoker patients (>400 cigarette/year) will suffer more postoperative complications than non-smoker patients after lobectomy. Evidences has suggested pulmonary rehabilitation could reduce the pulmonary complications after thoracic surgery. However, the effect and long-term results of pulmonary rehabilitation on smoker patients have not been studied. The purpose of this study is to determine whether pulmonary rehabilitation is effective to smoker patients who underwent lobectomy.

详细描述

In China, the smoker population is about 300 hundred million. Tobacco has become one of the world's public health problem. 30 percent of global surgery patients have smoking history. It is reported that smoker patients (>400 cigarette/year) will suffer more postoperative complications than non-smoker patients after lobectomy (38.2% vs 12.5%). Smoking is an independent risk factor of postoperative complications of cardiothoracic surgery. Evidences showed that smoking had a negative effect on airway management which plays an important role in postoperative recovery for thoracic surgery. Therefore, we hypothesise that intervention-related study to find a way to reduce postoperative complications for smoker patients is significantly meaningful in improving the overall outcome after pulmonary surgery as 80 percent of patients with lung cancer are smoker in China. Recently, a series of strategies on airway management have been proposed by clinical doctors. As one of the important parts of airway management, pulmonary rehabilitation has been demonstrated by evidence-base medicine to reduce the pulmonary complications after thoracic surgery and increase the breathing capacity. According to the reported literatures, the effect and long-term results of pulmonary rehabilitation on smoker patients have not been studied, so we designed this randomized controlled trial to determine whether pulmonary rehabilitation would be effective to smoker patients who underwent lobectomy which was associated with significant loss of lung function.

According to the reported papers in China, main observation index in experimental group was about 25.7, and in control group was about 10%. At the level of α=0.05 (Bilateral), power of test (1-β)=0.80, ratio=1:1. The estimated minimum required sample size of each group was 93 cases, the statistical loss rate was set as 10%. The overall sample size of this study was about 200 cases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
— 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • signed consent
  • smoker, ≥400/cigarette year
  • surgical approach: open or Video-assisted Thoracoscopic Surgery (VATS) lobectomy

排除标准

  • Serious physical diseases in patients during hospitalization, such as severe heart and lung diseases (CLASS III-IV) (FEV1/FVC <0.7and FEV1 <50% predicted value), kidney disease (ESRD change need to continue dialysis), or liver diseases (cirrhosis of the liver accompanied by ascites)
  • unable to obey interventional instructions/treatments because of any reasons
  • stage IV lung cancer
  • emergency surgery
  • lung cancer with preoperative chemotherapy, radiotherapy or chemoradiotherapy

结局指标

主要结局

postoperative pulmonary complications

时间窗: postoperative in-hospital stay up to 30 days

次要结局

  • length of stay (LOS)(postoperative in-hospital stay up to 90 days)
  • vital signs(before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery)
  • lung function test(before treatment, 3 days after surgery, 3 months after surgery, 6 months after surgery)
  • therapeutic time of antibiotics(Postoperative in-hospital stay up to 30 days)
  • total hospitalization expenditures(postoperative in-hospital stay up to 30 days)
  • arterial blood gas analysis(before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery)
  • pain score of expectoration(1 day and 3 days after surgery)
  • amount of expectoration drainage(postoperative in-hospital stay up to 30 days)
  • peak expiratory flow(before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hecheng Li M.D., Ph.D

Professor

Ruijin Hospital

研究点 (1)

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