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

NCT ID: NCT02146092

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 389 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-01
• Study Completion Date: 2017-06-30

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.

Conditions

Lung Neoplasms; Benign Lung Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Physiotherapy

Intervention Type: OTHER

Standard of care exercise training and supervision

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.

Group Type: EXPERIMENTAL

Incentive spirometry

Intervention Type: PROCEDURE

Physiotherapy

Intervention Type: OTHER

Standard of care exercise training and supervision

Interventions

Incentive spirometry

Intervention Type: PROCEDURE

Physiotherapy

Standard of care exercise training and supervision

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster Surgical Associates

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wael C Hanna, MDCM MBA FRCSC FCCP

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

SJHH_Spirometry001

Identifier Type: -

Identifier Source: org_study_id