Effect of Pulmonary Rehabilitation on Perioperative Outcomes in Smoker Patients With Lung Cancer

Pulmonary Neoplasm Clinical Trial

— PREPOSE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03010033
• Other study ID #: RTS-001
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2017
• Est. completion date: December 2022

Study information

• Verified date: October 2021
• Source: Ruijin Hospital
• Contact: Ding-Pei Han, master
• Phone: 00862164370045
• Email: dmhan1985[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Pulmonary Neoplasm

Intervention

Other:
• pulmonary rehabilitation
pulmonary rehabilitation (preoperative part): lower extremity endurance training (using bike ergometer for 3 days, 2 times/day, 15-20min/time) or stair climbing training (3 days, 2 times/day, 30min/time), keep dyspnea index (Borg) score between 5 to 7 points. And inspiratory muscle training (using threshold inspiratory muscle trainer for 3 days, 5 times/day, 2 sessions/time, every session includes 10-20 cycle respirations). pulmonary rehabilitation (postoperative part): inspiratory muscle training (using threshold inspiratory muscle trainer until hospital discharge, 3-5 times/day, 1 session/time, every session includes 10-20 cycle respirations).

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai JiaoTong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pulmonary complications		postoperative in-hospital stay up to 30 days
Secondary	length of stay (LOS)		postoperative in-hospital stay up to 90 days
Secondary	therapeutic time of antibiotics		Postoperative in-hospital stay up to 30 days
Secondary	arterial blood gas analysis		before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery
Secondary	vital signs		before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery
Secondary	pain score of expectoration	Visual Analogue Scale (VAS) Pain Score	1 day and 3 days after surgery
Secondary	amount of expectoration drainage		postoperative in-hospital stay up to 30 days
Secondary	peak expiratory flow		before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery
Secondary	lung function test		before treatment, 3 days after surgery, 3 months after surgery, 6 months after surgery
Secondary	total hospitalization expenditures		postoperative in-hospital stay up to 30 days