Clinical trial NCT03010033: Effect of Pulmonary Rehabilitation on Perioperative Outcomes in Smoker Patients With Lung Cancer
Official title: Effects of Pulmonary Rehabilitation and Airway Management on Short-term and Long-term Perioperative Results of Lobectomy in Smoker Patients With Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Neoplasm
Keywords: pulmonary rehabilitation
lobectomy
smoker
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 200
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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)
2. unable to obey interventional instructions/treatments because of any reasons
3. stage IV lung cancer
4. emergency surgery
5. lung cancer with preoperative chemotherapy, radiotherapy or chemoradiotherapy

Primary outcomes:
measure: postoperative pulmonary complications
timeFrame: postoperative in-hospital stay up to 30 days
Secondary outcomes:
measure: length of stay (LOS)
timeFrame: postoperative in-hospital stay up to 90 days
measure: therapeutic time of antibiotics
timeFrame: Postoperative in-hospital stay up to 30 days
measure: arterial blood gas analysis
timeFrame: before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery
measure: vital signs
timeFrame: before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery
measure: pain score of expectoration
timeFrame: 1 day and 3 days after surgery
measure: amount of expectoration drainage
timeFrame: postoperative in-hospital stay up to 30 days
measure: peak expiratory flow
timeFrame: before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery
measure: lung function test
timeFrame: before treatment, 3 days after surgery, 3 months after surgery, 6 months after surgery
measure: total hospitalization expenditures
timeFrame: postoperative in-hospital stay up to 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: He-Cheng Li, doctor
role: PRINCIPAL_INVESTIGATOR
References: