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

NCT02146092 | Completed Phase 2

• 1 other identifier: SJHH_Spirometry001
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms; Benign Lung Disease

Keywords

lung resection; incentive spirometry; physiotherapy; quality improvement; outcomes; post operative complications

Outcome Measures

Primary Outcomes (1)

• Rate of post operative pulmonary complications within 30 days of 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

  30 days after surgery

Secondary Outcomes (4)

• Duration of oxygen treatment in hospital

  30 days post-surgery

• Length of hospital stay

  30 days after surgery

• Re-admission to hospital

  30 days

• Cost effectiveness of spirometry utilization

  30 days after surgery

Study Arms (2)

Standard physiotherapy

ACTIVE COMPARATOR

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

Incentive Spirometry

EXPERIMENTAL

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

Interventions

Incentive spirometry PROCEDURE

Incentive Spirometry

Physiotherapy OTHER

Standard of care exercise training and supervision

Incentive Spirometry; Standard physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• McMaster Surgical Associates: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Wael C Hanna, MDCM MBA FRCSC FCCP

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 23, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: February 14, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)