Lung NeoplasmsPhase 2NCT02146092
Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery
A Phase 2 study testing Incentive spirometry and Physiotherapy in people with Lung Neoplasms and Benign Lung Disease, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Benign Lung Disease
- What is being tested?
- Incentive spirometry and Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2014to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery: A Prospective Blinded Randomized Trial
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.
Read the 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
- Being tested
- Incentive spirometry, Physiotherapy
- Keywords
- lung resection, incentive spirometry, physiotherapy, quality improvement, outcomes, post operative complications
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incentive spirometryProcedure or surgery
PhysiotherapyOther
Standard of care exercise training and supervision
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Incentive spirometry; Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days after surgery
Secondary outcomes (4)
Duration of oxygen treatment in hospital
Use of oxygen therapy required while in hospital
Measured: 30 days post-surgery
Length of hospital stay
Measured: 30 days after surgery
Re-admission to hospital
Re-admission to hospital due to post operative pulmonary complications
Measured: 30 days
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
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study start1 Aug 2014
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster Surgical Associates
- Responsible party
- Sponsor
- Investigators
- Wael C Hanna, MDCM MBA FRCSC FCCP, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146092
- Sponsor's protocol ID
- SJHH_Spirometry001
- Status last verified
- Feb 2018
- First submitted
- 12 May 2014
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentive Spirometry Added to Physiotherapy to Reduce Postoperative Pulmonary Complications After Lung Surgery: A Prospective Blinded Randomized Trial
- ClinicalTrials.gov ID
- NCT02146092
- Acronym / sponsor ID
- SJHH_Spirometry001
- Conditions
- Lung Neoplasms, Benign Lung Disease
- Keywords
- lung resection, incentive spirometry, physiotherapy, quality improvement, outcomes, post operative complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- McMaster Surgical Associates
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard physiotherapy | Active comparator | Other: PhysiotherapyStandard 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. |
| Incentive Spirometry | Experimental | Procedure: Incentive spirometry, Other: PhysiotherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incentive spirometry | Procedure or surgery | Incentive Spirometry |
| PhysiotherapyStandard of care exercise training and supervision | Other | Incentive Spirometry, Standard physiotherapy |
Primary outcome
Rate of post operative pulmonary complications within 30 days of surgery
Time frame: 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
4 secondary outcomes
Duration of oxygen treatment in hospital
Time frame: 30 days post-surgery
Length of hospital stay
Time frame: 30 days after surgery
Re-admission to hospital
Time frame: 30 days
Cost effectiveness of spirometry utilization
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wael C Hanna, MDCM MBA FRCSC FCCP principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Incentive spirometry and Physiotherapy in people with Lung Neoplasms and Benign Lung Disease, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of post operative pulmonary complications within 30 days of surgery (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.