Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery

Phase 2

Completed

• Conditions: Lung Neoplasms; Benign Lung Disease

• Registration Number: NCT02146092
• Lead Sponsor: McMaster University

Brief Summary

After any surgery, there is a chance of complications. After lung surgery to remove tumours, there is a particularly high chance of a person developing an infection or needing help breathing, called post operative pulmonary complications. Currently, the risk of these complications is reduced through the completion of light physical and deep breathing exercises and walking around as soon as possible after surgery. Another possible way of helping these patients is to use a small device called an Incentive Spirometer to encourage and measure deep breathing. This study wants to compare how often postoperative pulmonary complications happen after major lung surgery between a group completing the exercises alone and a group using the Incentive spirometer in addition to the exercises. It is hoped that the combined therapy will reduce the amount of time patient must stay in hospital, have fewer complication events and have fewer patients re-admitted back into the hospital after they go home, so that patients overall have better outcomes.

Detailed Description

This study is a prospective blinded randomized control trial (RCT) where two arms will be assembled. Consenting eligible patients will be randomized to either the physiotherapy + incentive spirometry (PT+IS-intervention) arm or physiotherapy only (PT-control arm). Patients will be randomized with an equal (1:1) chance of being allocated to either the PT (control) arm or PT+IS (intervention) arm. Both the treating surgeon and data interpreter will be blinded to the intervention.

Study Timeline

• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-23
• Study Start: 2014-08-01
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

Inclusion Criteria

• Patients must be at minimum age 18
• Patient must be undergoing pulmonary resection surgery for malignant or benign disease
• Patients must be able to understand English
• Patients must be able to demonstrate aptitude and willingness to comply with describes study procedures

Exclusion Criteria

• Patients who are unable to read and communicate in English
• Home oxygen usage prior to operation
• Previous pulmonary resection or any thoracic surgery
• Radiological evidence of atelectasis or pneumonitis on preoperative imaging
• Radiological evidence of pleural effusion prior on preoperative imaging
• Prior exposure to pulmonotoxic drugs such as amiodarone or belomycin
• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of post operative pulmonary complications within 30 days of surgery	30 days after surgery	Postoperative pulmonary complications (PPCs) are defined as: * Pneumonia requiring treatment with antibiotics; * Atelectasis requiring pulmonary toilet by bronchoscopy; * Respiratory failure requiring treatment via mechanical ventilation (invasive or non-invasive); * Requirement for home oxygen after surgery, when this was not the case prior to surgery

Secondary Outcome Measures

Name	Time	Method
Duration of oxygen treatment in hospital	30 days post-surgery	Use of oxygen therapy required while in hospital
Length of hospital stay	30 days after surgery
Re-admission to hospital	30 days	Re-admission to hospital due to post operative pulmonary complications
Cost effectiveness of spirometry utilization	30 days after surgery	Calculated as an aggregate measure considering length of hospital stay, readmission to hospital and cost of treating complications. A cost value will be assigned to each group and compared for cost-benefit relationships

Trial Locations

Locations (1)

St. Joseph's Healthcare Hamilton; 🇨🇦 Hamilton, Ontario, Canada