Clinical trial NCT02146092: Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery
Official title: Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery: A Prospective Blinded Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasms
Benign Lung Disease
Keywords: lung resection
incentive spirometry
physiotherapy
quality improvement
outcomes
post operative complications
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster Surgical Associates
First posted: 2014-05-23
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Rate of post operative pulmonary complications within 30 days of surgery
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Duration of oxygen treatment in hospital
timeFrame: 30 days post-surgery
measure: Length of hospital stay
timeFrame: 30 days after surgery
measure: Re-admission to hospital
timeFrame: 30 days
measure: Cost effectiveness of spirometry utilization
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Wael C Hanna, MDCM MBA FRCSC FCCP
role: PRINCIPAL_INVESTIGATOR
References: