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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Neoplasm
• Intervention / Treatment: Other: pulmonary rehabilitation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ding-Pei Han, master; Phone Number: 666112 00862164370045; Email: dmhan1985@163.com
• Study Contact Backup: Name: He-Cheng Li, doctor; Phone Number: 666112 00862164370045; Email: lihecheng2000@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 021
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Ding-Pei Han, master; Phone Number: 666112 00862164370045; Email: dmhan1985@163.com
      • Contact: He-Cheng Li, doctor; Phone Number: 666112 00862164370045; Email: lihecheng2000@163.com
      • Sub-Investigator: Ding-Pei Han, master
      • Sub-Investigator: Run-Sen Jin, doctor
      • Sub-Investigator: Ya-Jie Zhang, doctor
      • Sub-Investigator: Jie Xiang, bachelor
      • Sub-Investigator: Kai Chen, master
      • Sub-Investigator: Hai-Lei Du, master
      • Sub-Investigator: Jia-Ming Che, bachelor
      • Sub-Investigator: Jun-Biao Hang, bachelor
      • Sub-Investigator: Liang-Gang Zhu, master
      • Sub-Investigator: Xiao-Qing Yang, master
      • Sub-Investigator: Xiang Zhou, master
      • Sub-Investigator: Jian Ren, bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: regular care; [Control group] preoperative treatment: smoking cession, aerosol inhalation for expectorant and antiasthmatic, anti-infection therapy if necessary and regular rehabilitation-propaganda; postoperative treatment: regular postoperative treatment (anti-infection, pain control, oxygen Inhalation aerosol inhalation for expectorant and antiasthmatic), patting back (3 times/day, 15min/time) and early ambulation unless serious patients.
EXPERIMENTAL: pulmonary rehabilitation; [Study group] preoperative treatment: smoking cession, aerosol inhalation for expectorant and antiasthmatic, anti-infection therapy if necessary, regular rehabilitation-propaganda and interventional pulmonary rehabilitation (preoperative part); postoperative treatment: regular postoperative treatment (anti-infection, pain control, oxygen Inhalation aerosol inhalation for expectorant and antiasthmatic), patting back (3 times/day, 15min/time), early ambulation unless serious patients and interventional pulmonary rehabilitation (postoperative part).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
postoperative pulmonary complications	postoperative in-hospital stay up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of stay (LOS)		postoperative in-hospital stay up to 90 days
therapeutic time of antibiotics		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
vital signs		before treatment, 3 days after treatment, 1 day after surgery, 3 days after surgery
pain score of expectoration	Visual Analogue Scale (VAS) Pain Score	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
lung function test		before treatment, 3 days after surgery, 3 months after surgery, 6 months after surgery
total hospitalization expenditures		postoperative in-hospital stay up to 30 days

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2017
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: December 26, 2016
• First Submitted That Met QC Criteria: January 1, 2017
• First Posted (ESTIMATE): January 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation; lobectomy; smoker
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: RTS-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No