NCT02146092

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

Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery: A Prospective Blinded Randomized Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 389 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Neoplasms
• Benign Lung Disease

Interventions

Type	Name	Description
PROCEDURE	Incentive spirometry
OTHER	Physiotherapy	Standard of care exercise training and supervision

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2014-05-23
• Last updated: 2018-02-14

Locations

1 site across 1 country: Canada