Back to resultsIncentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery
Primary Purpose
Lung Neoplasms, Benign Lung Disease
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Incentive spirometry
Physiotherapy
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Neoplasms focused on measuring lung resection, incentive spirometry, physiotherapy, quality improvement, outcomes, post operative complications
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
Sites / Locations
- St. Joseph's Healthcare Hamilton
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard physiotherapy
Incentive Spirometry
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Duration of oxygen treatment in hospital
Use of oxygen therapy required while in hospital
Length of hospital stay
Re-admission to hospital
Re-admission to hospital due to post operative pulmonary complications
Cost effectiveness of spirometry utilization
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
Full Information
NCT ID
NCT02146092
First Posted
May 12, 2014
Last Updated
February 13, 2018
Sponsor
McMaster University
Collaborators
McMaster Surgical Associates
1. Study Identification
Unique Protocol Identification Number
NCT02146092
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
McMaster Surgical Associates
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Benign Lung Disease
Keywords
lung resection, incentive spirometry, physiotherapy, quality improvement, outcomes, post operative complications
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
389 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard physiotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Incentive Spirometry
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Incentive spirometry
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Standard of care exercise training and supervision
Primary Outcome Measure Information:
Title
Rate of post operative pulmonary complications within 30 days of surgery
Description
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
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Duration of oxygen treatment in hospital
Description
Use of oxygen therapy required while in hospital
Time Frame
30 days post-surgery
Title
Length of hospital stay
Time Frame
30 days after surgery
Title
Re-admission to hospital
Description
Re-admission to hospital due to post operative pulmonary complications
Time Frame
30 days
Title
Cost effectiveness of spirometry utilization
Description
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
Time Frame
30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wael C Hanna, MDCM MBA FRCSC FCCP
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery
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