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

Sponsor

McMaster University (Other)

Overall Status

Completed

CT.gov ID

NCT02146092

Collaborator

McMaster Surgical Associates (Other)

389

Enrollment

Location

Arms

Actual Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms Benign Lung Disease	Procedure: Incentive spirometry Other: Physiotherapy	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

389 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard physiotherapy Standard physiotherapy includes routine physiotherapy care as per current institutional standards. This consists of two daily visits by the physiotherapist. During the visits, the patient will be taught deep breathing and will be instructed to practice it 10 times every hour. They are also shown shoulder movements and lung expansion exercises. They will receive a sheet summarizing the exercises for future reference. The patient is discharged from physiotherapy when they are ambulatory, on room air, and able to clear their respiratory secretions independently, although they will be asked to continue the exercises on their own until 30 days from surgery.	Other: Physiotherapy Standard of care exercise training and supervision
Experimental: Incentive Spirometry Patients in the Incentive Spirometry arm will receive standard physiotherapy care in addition to training and use of an incentive spirometer. The physiotherapy care includes routine care as per current institutional standards. They will also receive an incentive spirometer on the first postoperative day and will be taught how to use it with an accompanying instructional sheet for later reference. Teaching will emphasize slow deep breathing, sustained vacuum pressure, and gradual increase in difficulty. Patients will be instructed to use the spirometer 10 times every hour until 30 days after surgery.	Procedure: Incentive spirometry Other: Physiotherapy Standard of care exercise training and supervision

Arm

Intervention/Treatment

Active Comparator: Standard physiotherapy

Standard physiotherapy includes routine physiotherapy care as per current institutional standards. This consists of two daily visits by the physiotherapist. During the visits, the patient will be taught deep breathing and will be instructed to practice it 10 times every hour. They are also shown shoulder movements and lung expansion exercises. They will receive a sheet summarizing the exercises for future reference. The patient is discharged from physiotherapy when they are ambulatory, on room air, and able to clear their respiratory secretions independently, although they will be asked to continue the exercises on their own until 30 days from surgery.

Other: Physiotherapy

Standard of care exercise training and supervision

Experimental: Incentive Spirometry

Patients in the Incentive Spirometry arm will receive standard physiotherapy care in addition to training and use of an incentive spirometer. The physiotherapy care includes routine care as per current institutional standards. They will also receive an incentive spirometer on the first postoperative day and will be taught how to use it with an accompanying instructional sheet for later reference. Teaching will emphasize slow deep breathing, sustained vacuum pressure, and gradual increase in difficulty. Patients will be instructed to use the spirometer 10 times every hour until 30 days after surgery.

Procedure: Incentive spirometry

Other: Physiotherapy

Standard of care exercise training and supervision

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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