Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery
Conditions
Lung Neoplasms - Benign Lung Disease
Conditions: official terms
Lung Diseases - Lung Neoplasms
Conditions: Keywords
lung resection, incentive spirometry, physiotherapy, quality improvement, outcomes, post operative complications
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
Intervention
Name: Incentive spirometry Type: Procedure
Name: Physiotherapy Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Status: Recruiting
Start Date
August 2014
Completion Date
March 2016
Sponsors
McMaster University
Source
McMaster University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page