Postoperative Respiratory ComplicationNCT04732143
Effect of Preoperative Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection
A study testing Inspiratory muscle training in people with Postoperative Respiratory Complication, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The objective of this study is to demonstrate that inspiratory muscle training with daily use of an incentive spirometer for at least 14 days prior to lung surgery will reduce the risk of post-operative pulmonary complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Respiratory Complication
- What is being tested?
- Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 7 Jun 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ECOG performance status score 2 or less
- Undergoing elective lung resection (includes wedge resection, lobectomy, bi-lobectomy, pneumonectomy, sleeve resection) via minimally invasive (VATS or robotic) approach or thoracotomy
- Chest wall resection if performed concurrently with lung resection
Who cannot join
- ECOG performance status score greater than 2
- Significant cognitive impairment preventing informed consent
- Non-English speaking
- Wedge biopsy for interstitial lung disease
- Bullectomy for bullous emphysema
- Pre-existing tracheostomy
Show all 10Show fewer
- Emergent or urgent surgery
- Preoperative home oxygen use
- History of neuromuscular disease
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: The Effect of Preoperative Inspiratory Muscle Training Using Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection
The objective of this study is to demonstrate that inspiratory muscle training with daily use of an incentive spirometer for at least 14 days prior to lung surgery will reduce the risk of post-operative pulmonary complications.
Read the detailed description
Postoperative pulmonary complications (PPC) are the most common adverse events following lung resection, with a reported incidence of over 20-30% in some series. The objective of this study is to demonstrate that inspiratory muscle training (IMT) with daily use of an incentive spirometer (IS) for at least 14 days prior to lung surgery will reduce the risk of PPCs compared to the usual care, consisting of no formal preoperative IMT. The hypothesis is that preoperative inspiratory spirometer breathing (ISB) is a feasible and cost-effective intervention that can significantly reduce PPCs after lung resection. It is also hypothesized that patient compliance with the intervention will be high because of its simplicity, convenience, low cost and no potential for adverse effects.
- Conditions
- Postoperative Respiratory Complication
- Being tested
- Inspiratory muscle training
- Keywords
- Incentive Spirometry, Inspiratory Muscle Training, Pulmonary Resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
Also called Incentive spirometry
At least 2 weeks prior to surgery, participants will be given a Vyaire incentive spirometer device and provided with formal training on proper inspiratory muscle breathing exercise using the device. They will be instructed to perform 4 sets of these exercises per day for 14 days prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Incentive Spirometry | Experimental | Participants will undergo inspiratory muscle training using an incentive spirometer daily for 14 days prior to surgery. Receives: Other: Inspiratory muscle training |
| Standard Care | No intervention | Participants will not undergo any inspiratory muscle training prior to surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atelectasis
Incidence of atelectasis requiring bronchoscopy or additional bedside therapy by a respiratory therapist
Measured: Through completion of follow-up (30 days)
Pneumonia
Clinical and/or radiographic evidence of pneumonia requiring antibiotic therapy
Measured: Through completion of follow-up (30 days)
Respiratory failure
Incidence of respiratory failure requiring re-intubation or high flow nasal cannula and/or non-invasive positive pressure ventilation
Measured: Through completion of follow-up (30 days)
Pleural effusion
Incidence of pleural effusion requiring drainage or other medical intervention (e.g. use of diuretics)
Measured: Through completion of follow-up (30 days)
Pneumothorax or subcutaneous emphysema
Incidence of clinically significant pneumothorax or subcutaneous emphysema requiring intervention or extended hospital admission for observation
Measured: Through completion of follow-up (30 days)
Prolonged air leak
Incidence of prolonged air leak (>5 days) or requiring discharge with chest tube
Measured: Through completion of follow-up (30 days)
Need for supplemental oxygen
Incidence of patients requiring supplemental oxygen upon discharge
Measured: Through completion of follow-up (30 days)
Empyema/bronchopleural fistula
Incidence of empyema and/or bronchopleural fistula confirmed by fluid analysis and/or cultures
Measured: Through completion of follow-up (30 days)
Cardiac arrhythmia
Incidence of cardiac arrhythmia requiring intervention (e.g. atrial fibrillation, supraventricular tachycardia, etc.)
Measured: Through completion of follow-up (30 days)
Secondary outcomes (6)
Hospital length of stay
Total length of index admission following surgery
Measured: Through completion of follow-up (30 days)
ICU length of stay
If participant required ICU admission
Measured: Through completion of follow-up (30 days)
Chest tube duration
Number of days from chest tube insertion (surgery date) until chest tube removal
Measured: Through completion of follow-up (30 days)
Hospital readmission
Participant visited an emergency department and/or was admitted to the hospital following discharge from the index admission for any reason.
Measured: Through completion of follow-up (30 days)
Change from baseline in dyspnea, measured by the modified Medical Research Council scale
Scores are measured on a scale from 0 to 4, with 0 indicating dyspnea only with strenuous exercise and 4 indicating participant is too dyspneic to leave the house or breathless when dressing
Measured: Baseline, 2 weeks and 4 weeks after surgery
Mortality
Death from any cause
Measured: Through completion of follow-up (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start27 Apr 2021
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
Why it stopped: Lack of funding and clinical resources to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative Respiratory ComplicationStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pauline Go, Milton S. Hershey Medical Center
- Investigators
- Pauline H Go, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732143
- Sponsor's protocol ID
- STUDY00015501
- Status last verified
- Jun 2023
- First submitted
- 27 Jan 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pehlivan E, Turna A, Gurses A, Gurses HN. The effects of preoperative short-term intense physical therapy in lung cancer patients: a randomized controlled trial. Ann Thorac Cardiovasc Surg. 2011;17(5):461-8. doi: 10.5761/atcs.oa.11.01663. Epub 2011 Jul 13.
PubMed 21881371Gao K, Yu PM, Su JH, He CQ, Liu LX, Zhou YB, Pu Q, Che GW. Cardiopulmonary exercise testing screening and pre-operative pulmonary rehabilitation reduce postoperative complications and improve fast-track recovery after lung cancer surgery: A study for 342 cases. Thorac Cancer. 2015 Jul;6(4):443-9. doi: 10.1111/1759-7714.12199. Epub 2014 Dec 22.
PubMed 26273399Valkenet K, Trappenburg JCA, Ruurda JP, Guinan EM, Reynolds JV, Nafteux P, Fontaine M, Rodrigo HE, van der Peet DL, Hania SW, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJG, Faber T, Kouwenhoven EA, Tinselboer M, Rasanen J, Ryynanen H, Gosselink R, van Hillegersberg R, Backx FJG. Multicentre randomized clinical trial of inspiratory muscle training versus usual care before surgery for oesophageal cancer. Br J Surg. 2018 Apr;105(5):502-511. doi: 10.1002/bjs.10803.
PubMed 29603130Weiner P, Man A, Weiner M, Rabner M, Waizman J, Magadle R, Zamir D, Greiff Y. The effect of incentive spirometry and inspiratory muscle training on pulmonary function after lung resection. J Thorac Cardiovasc Surg. 1997 Mar;113(3):552-7. doi: 10.1016/S0022-5223(97)70370-2.
PubMed 9081102Benzo R, Wigle D, Novotny P, Wetzstein M, Nichols F, Shen RK, Cassivi S, Deschamps C. Preoperative pulmonary rehabilitation before lung cancer resection: results from two randomized studies. Lung Cancer. 2011 Dec;74(3):441-5. doi: 10.1016/j.lungcan.2011.05.011. Epub 2011 Jun 12.
PubMed 21663994
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Inspiratory Muscle Training Using Incentive Spirometer on Postoperative Pulmonary Complications Following Lung Resection
- ClinicalTrials.gov ID
- NCT04732143
- Acronym / sponsor ID
- STUDY00015501
- Conditions
- Postoperative Respiratory Complication
- Keywords
- Incentive Spirometry, Inspiratory Muscle Training, Pulmonary Resection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding and clinical resources to continue
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 1 Feb 2021 (actual)
- 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.
The objective of this study is to demonstrate that inspiratory muscle training with daily use of an incentive spirometer for at least 14 days prior to lung surgery will reduce the risk of post-operative pulmonary complications.
Detailed description
Postoperative pulmonary complications (PPC) are the most common adverse events following lung resection, with a reported incidence of over 20-30% in some series. The objective of this study is to demonstrate that inspiratory muscle training (IMT) with daily use of an incentive spirometer (IS) for at least 14 days prior to lung surgery will reduce the risk of PPCs compared to the usual care, consisting of no formal preoperative IMT. The hypothesis is that preoperative inspiratory spirometer breathing (ISB) is a feasible and cost-effective intervention that can significantly reduce PPCs after lung resection. It is also hypothesized that patient compliance with the intervention will be high because of its simplicity, convenience, low cost and no potential for adverse effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incentive Spirometry | Experimental | Other: Inspiratory muscle trainingParticipants will undergo inspiratory muscle training using an incentive spirometer daily for 14 days prior to surgery. |
| Standard Care | No intervention | –Participants will not undergo any inspiratory muscle training prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ECOG performance status score 2 or less
- Undergoing elective lung resection (includes wedge resection, lobectomy, bi-lobectomy, pneumonectomy, sleeve resection) via minimally invasive (VATS or robotic) approach or thoracotomy
- Chest wall resection if performed concurrently with lung resection
Key exclusion criteria (10 listed)
- ECOG performance status score greater than 2
- Significant cognitive impairment preventing informed consent
- Non-English speaking
- Wedge biopsy for interstitial lung disease
- Bullectomy for bullous emphysema
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 |
|---|---|---|
| Inspiratory muscle trainingAlso: Incentive spirometryAt least 2 weeks prior to surgery, participants will be given a Vyaire incentive spirometer device and provided with formal training on proper inspiratory muscle breathing exercise using the device. They will be instructed to perform 4 sets of these exercises per day for 14 days prior to surgery. | Other | Incentive Spirometry |
Primary outcome
Atelectasis
Time frame: Through completion of follow-up (30 days)
Incidence of atelectasis requiring bronchoscopy or additional bedside therapy by a respiratory therapist
Pneumonia
Time frame: Through completion of follow-up (30 days)
Clinical and/or radiographic evidence of pneumonia requiring antibiotic therapy
Respiratory failure
Time frame: Through completion of follow-up (30 days)
Incidence of respiratory failure requiring re-intubation or high flow nasal cannula and/or non-invasive positive pressure ventilation
Pleural effusion
Time frame: Through completion of follow-up (30 days)
Incidence of pleural effusion requiring drainage or other medical intervention (e.g. use of diuretics)
Pneumothorax or subcutaneous emphysema
Time frame: Through completion of follow-up (30 days)
Incidence of clinically significant pneumothorax or subcutaneous emphysema requiring intervention or extended hospital admission for observation
Prolonged air leak
Time frame: Through completion of follow-up (30 days)
Incidence of prolonged air leak (>5 days) or requiring discharge with chest tube
Need for supplemental oxygen
Time frame: Through completion of follow-up (30 days)
Incidence of patients requiring supplemental oxygen upon discharge
Empyema/bronchopleural fistula
Time frame: Through completion of follow-up (30 days)
Incidence of empyema and/or bronchopleural fistula confirmed by fluid analysis and/or cultures
Cardiac arrhythmia
Time frame: Through completion of follow-up (30 days)
Incidence of cardiac arrhythmia requiring intervention (e.g. atrial fibrillation, supraventricular tachycardia, etc.)
6 secondary outcomes
Hospital length of stay
Time frame: Through completion of follow-up (30 days)
ICU length of stay
Time frame: Through completion of follow-up (30 days)
Chest tube duration
Time frame: Through completion of follow-up (30 days)
Hospital readmission
Time frame: Through completion of follow-up (30 days)
Change from baseline in dyspnea, measured by the modified Medical Research Council scale
Time frame: Baseline, 2 weeks and 4 weeks after surgery
Mortality
Time frame: Through completion of follow-up (30 days)
Results and safety
The study was stopped early (reason given: Lack of funding and clinical resources to continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Background: PubMed 21881371Pehlivan E, Turna A, Gurses A, Gurses HN. The effects of preoperative short-term intense physical therapy in lung cancer patients: a randomized controlled trial. Ann Thorac Cardiovasc Surg. 2011;17(5):461-8. doi: 10.5761/atcs.oa.11.01663. Epub 2011 Jul 13.
- Background: PubMed 26273399Gao K, Yu PM, Su JH, He CQ, Liu LX, Zhou YB, Pu Q, Che GW. Cardiopulmonary exercise testing screening and pre-operative pulmonary rehabilitation reduce postoperative complications and improve fast-track recovery after lung cancer surgery: A study for 342 cases. Thorac Cancer. 2015 Jul;6(4):443-9. doi: 10.1111/1759-7714.12199. Epub 2014 Dec 22.
- Background: PubMed 29603130Valkenet K, Trappenburg JCA, Ruurda JP, Guinan EM, Reynolds JV, Nafteux P, Fontaine M, Rodrigo HE, van der Peet DL, Hania SW, Sosef MN, Willms J, Rosman C, Pieters H, Scheepers JJG, Faber T, Kouwenhoven EA, Tinselboer M, Rasanen J, Ryynanen H, Gosselink R, van Hillegersberg R, Backx FJG. Multicentre randomized clinical trial of inspiratory muscle training versus usual care before surgery for oesophageal cancer. Br J Surg. 2018 Apr;105(5):502-511. doi: 10.1002/bjs.10803.
- Background: PubMed 9081102Weiner P, Man A, Weiner M, Rabner M, Waizman J, Magadle R, Zamir D, Greiff Y. The effect of incentive spirometry and inspiratory muscle training on pulmonary function after lung resection. J Thorac Cardiovasc Surg. 1997 Mar;113(3):552-7. doi: 10.1016/S0022-5223(97)70370-2.
- Background: PubMed 21663994Benzo R, Wigle D, Novotny P, Wetzstein M, Nichols F, Shen RK, Cassivi S, Deschamps C. Preoperative pulmonary rehabilitation before lung cancer resection: results from two randomized studies. Lung Cancer. 2011 Dec;74(3):441-5. doi: 10.1016/j.lungcan.2011.05.011. Epub 2011 Jun 12.
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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.
Pauline H Go, MD principal investigator
Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Postoperative Respiratory Complication, run by Milton S. Hershey Medical Center at 1 site in United States.
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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 13 Jun 2023. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Lack of funding and clinical resources to continue). Results are not available in the source record.
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?
Atelectasis (time frame: Through completion of follow-up (30 days)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04732143, which also lists 5 linked publications.
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 13 Jun 2023.