Postoperative Pulmonary ComplicationsNCT07867548
Intermittent Positive Pressure Breathing Versus Incentive Spirometry After Thoracic Surgery
A study testing Intermittent Positive Pressure Breathing and Incentive Spirometry in people with Postoperative Pulmonary Complications and Thoracic Surgery, run by Fu Jen Catholic University Hospital.
Trial summary
This randomized controlled pilot study will compare intermittent positive pressure breathing (IPPB) with incentive spirometry (IS) in adult patients undergoing thoracic surgery. The study aims to evaluate the effects of these two postoperative pulmonary rehabilitation interventions on lung volume recovery, respiratory… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pulmonary Complications, Thoracic Surgery
- What is being tested?
- Intermittent Positive Pressure Breathing and Incentive Spirometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Willing and able to provide written informed consent. Adults aged 18 years or older. Undergoing thoracic surgery. Considered eligible by a specialist physician to participate in pulmonary rehabilitation training.
Who cannot join
- Unable to cooperate with the study procedures. Untreated pneumothorax. Severe hemodynamic instability. Active hemoptysis or gastrointestinal bleeding. Intracranial pressure greater than 15 mmHg. Recent facial, oropharyngeal, or cranial surgery or injury. Tracheoesophageal fistula. Recent esophageal surgery. Nausea or vomiting. Pulmonary bullae identified on imaging.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of Intermittent Positive Pressure Breathing and Incentive Spirometry on Postoperative Pulmonary Complications and Lung Volume in Patients Undergoing Thoracic Surgery: A Randomized Controlled Trial
This randomized controlled pilot study will compare intermittent positive pressure breathing (IPPB) with incentive spirometry (IS) in adult patients undergoing thoracic surgery. The study aims to evaluate the effects of these two postoperative pulmonary rehabilitation interventions on lung volume recovery, respiratory muscle strength, oxygenation, pulmonary complications, and overall postoperative recovery. Participants will be randomly assigned to either the IPPB group or the IS group. Assessments will be performed before surgery and after the intervention period.
Read the detailed description
This is a single-center, randomized controlled pilot study conducted at Fu Jen Catholic University Hospital. A total of 30 adult patients undergoing thoracic surgery will be enrolled and randomly assigned to one of two intervention groups: intermittent positive pressure breathing (IPPB) or incentive spirometry (IS).
Before surgery, participants will undergo baseline assessments including blood sampling, lung volume measurement, chest X-ray, respiratory muscle strength assessment, and pulmonary function evaluation. After surgery, participants will receive the assigned pulmonary rehabilitation intervention from postoperative day 0 through postoperative day 3.
Participants assigned to the IS group will perform supervised slow and deep inspirations using an incentive spirometer 3 to 4 times per day, with three sets of 10 breaths per session. Participants will also be encouraged to practice independently while awake. Participants assigned to the IPPB group will receive intermittent positive pressure breathing as the postoperative lung expansion intervention according to the study protocol.
Follow-up assessments will be performed after the intervention period. Outcomes will include changes in lung volume; maximal inspiratory and expiratory pressures; physiologic parameters including heart rate, respiratory rate, and blood pressure; chest X-ray findings; pulmonary function; arterial blood gas measurements; peripheral oxygen saturation; dyspnea; pain; and postoperative pulmonary complications. Blood samples will also be collected to evaluate C-reactive protein as an indicator of postoperative inflammatory response.
The study is designed to evaluate the feasibility of the study procedures and to obtain preliminary estimates of treatment effects that may be used to inform the sample size and design of a future definitive randomized controlled trial.
- Being tested
- Intermittent Positive Pressure Breathing, Incentive Spirometry
- Keywords
- Intermittent Positive Pressure Breathing, Incentive Spirometry, Thoracic Surgery, Postoperative Pulmonary Complications, Pulmonary Rehabilitation, Lung Volume, Respiratory Muscle Strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Positive Pressure BreathingOther
Intermittent positive pressure breathing will be provided as a postoperative lung expansion intervention from postoperative day 0 through postoperative day 3.
Incentive SpirometryOther
Participants will perform incentive spirometry from postoperative day 0 through postoperative day 3 under therapist supervision 3 to 4 times per day. Each supervised session will consist of 3 sets of 10 slow, deep inspirations, with a 2- to 3-second inspiratory hold. Participants will also be encouraged to practice independently while awake.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Positive Pressure Breathing Group | Experimental | Participants assigned to this group will receive intermittent positive pressure breathing (IPPB) as the postoperative lung expansion intervention from postoperative day 0 through postoperative day 3. Receives: Other: Intermittent Positive Pressure Breathing |
| Incentive Spirometry Group | Active comparator | Participants assigned to this group will perform postoperative lung expansion training using incentive spirometry from postoperative day 0 through postoperative day 3. Receives: Other: Incentive Spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lung Volume
Change in lung volume, including tidal volume and minute ventilation, measured using a respiratory volume measurement device.
Measured: Baseline (preoperative) and postoperative day 3
Change in Maximal Inspiratory Pressure
Change in maximal inspiratory pressure (MIP) measured using a respiratory pressure measurement device to assess inspiratory muscle strength.
Measured: Baseline (preoperative) and postoperative day 3
Change in Maximal Expiratory Pressure
Change in maximal expiratory pressure (MEP) measured using a respiratory pressure measurement device to assess expiratory muscle strength.
Measured: Baseline (preoperative) and postoperative day 3
Secondary outcomes (1)
Change in C-Reactive Protein
Change in serum C-reactive protein (CRP) concentration as an indicator of postoperative inflammatory response.
Measured: Baseline (preoperative) and postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start12 Oct 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary ComplicationsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in parallel to either the intermittent positive pressure breathing group or the incentive spirometry group.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fu Jen Catholic University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Hung Kuo, M.S., Principal investigator, Fu Jen Catholic University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867548
- Sponsor's protocol ID
- FJUH115610
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.
PubMed 30304509Ludwig C, Angenendt S, Martins R, Mayer V, Stoelben E. Intermittent positive-pressure breathing after lung surgery. Asian Cardiovasc Thorac Ann. 2011 Feb;19(1):10-3. doi: 10.1177/0218492310394664.
PubMed 21357311Agostini P, Naidu B, Cieslik H, Steyn R, Rajesh PB, Bishay E, Kalkat MS, Singh S. Effectiveness of incentive spirometry in patients following thoracotomy and lung resection including those at high risk for developing pulmonary complications. Thorax. 2013 Jun;68(6):580-5. doi: 10.1136/thoraxjnl-2012-202785. Epub 2013 Feb 21.
PubMed 23429831
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intermittent Positive Pressure Breathing and Incentive Spirometry on Postoperative Pulmonary Complications and Lung Volume in Patients Undergoing Thoracic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07867548
- Acronym / sponsor ID
- FJUH115610
- Keywords
- Intermittent Positive Pressure Breathing, Incentive Spirometry, Thoracic Surgery, Postoperative Pulmonary Complications, Pulmonary Rehabilitation, Lung Volume, Respiratory Muscle Strength
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fu Jen Catholic University HospitalUniversity, hospital or other
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 9 Oct 2026 (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.
This randomized controlled pilot study will compare intermittent positive pressure breathing (IPPB) with incentive spirometry (IS) in adult patients undergoing thoracic surgery. The study aims to evaluate the effects of these two postoperative pulmonary rehabilitation interventions on lung volume recovery, respiratory muscle strength, oxygenation, pulmonary complications, and overall postoperative recovery. Participants will be randomly assigned to either the IPPB group or the IS group. Assessments will be performed before surgery and after the intervention period.
Detailed description
This is a single-center, randomized controlled pilot study conducted at Fu Jen Catholic University Hospital. A total of 30 adult patients undergoing thoracic surgery will be enrolled and randomly assigned to one of two intervention groups: intermittent positive pressure breathing (IPPB) or incentive spirometry (IS).
Before surgery, participants will undergo baseline assessments including blood sampling, lung volume measurement, chest X-ray, respiratory muscle strength assessment, and pulmonary function evaluation. After surgery, participants will receive the assigned pulmonary rehabilitation intervention from postoperative day 0 through postoperative day 3.
Participants assigned to the IS group will perform supervised slow and deep inspirations using an incentive spirometer 3 to 4 times per day, with three sets of 10 breaths per session. Participants will also be encouraged to practice independently while awake. Participants assigned to the IPPB group will receive intermittent positive pressure breathing as the postoperative lung expansion intervention according to the study protocol.
Follow-up assessments will be performed after the intervention period. Outcomes will include changes in lung volume; maximal inspiratory and expiratory pressures; physiologic parameters including heart rate, respiratory rate, and blood pressure; chest X-ray findings; pulmonary function; arterial blood gas measurements; peripheral oxygen saturation; dyspnea; pain; and postoperative pulmonary complications. Blood samples will also be collected to evaluate C-reactive protein as an indicator of postoperative inflammatory response.
The study is designed to evaluate the feasibility of the study procedures and to obtain preliminary estimates of treatment effects that may be used to inform the sample size and design of a future definitive randomized controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in parallel to either the intermittent positive pressure breathing group or the incentive spirometry group.
| Arm | Type | Receives |
|---|---|---|
| Intermittent Positive Pressure Breathing Group | Experimental | Other: Intermittent Positive Pressure BreathingParticipants assigned to this group will receive intermittent positive pressure breathing (IPPB) as the postoperative lung expansion intervention from postoperative day 0 through postoperative day 3. |
| Incentive Spirometry Group | Active comparator | Other: Incentive SpirometryParticipants assigned to this group will perform postoperative lung expansion training using incentive spirometry from postoperative day 0 through postoperative day 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Willing and able to provide written informed consent. Adults aged 18 years or older. Undergoing thoracic surgery. Considered eligible by a specialist physician to participate in pulmonary rehabilitation training.
Key exclusion criteria (1 listed)
- Unable to cooperate with the study procedures. Untreated pneumothorax. Severe hemodynamic instability. Active hemoptysis or gastrointestinal bleeding. Intracranial pressure greater than 15 mmHg. Recent facial, oropharyngeal, or cranial surgery or injury. Tracheoesophageal fistula. Recent esophageal surgery. Nausea or vomiting. Pulmonary bullae identified on 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 |
|---|---|---|
| Intermittent Positive Pressure BreathingIntermittent positive pressure breathing will be provided as a postoperative lung expansion intervention from postoperative day 0 through postoperative day 3. | Other | Intermittent Positive Pressure Breathing Group |
| Incentive SpirometryParticipants will perform incentive spirometry from postoperative day 0 through postoperative day 3 under therapist supervision 3 to 4 times per day. Each supervised session will consist of 3 sets of 10 slow, deep inspirations, with a 2- to 3-second inspiratory hold. Participants will also be encouraged to practice independently while awake. | Other | Incentive Spirometry Group |
Primary outcome
Change in Lung Volume
Time frame: Baseline (preoperative) and postoperative day 3
Change in lung volume, including tidal volume and minute ventilation, measured using a respiratory volume measurement device.
Change in Maximal Inspiratory Pressure
Time frame: Baseline (preoperative) and postoperative day 3
Change in maximal inspiratory pressure (MIP) measured using a respiratory pressure measurement device to assess inspiratory muscle strength.
Change in Maximal Expiratory Pressure
Time frame: Baseline (preoperative) and postoperative day 3
Change in maximal expiratory pressure (MEP) measured using a respiratory pressure measurement device to assess expiratory muscle strength.
1 secondary outcome
Change in C-Reactive Protein
Time frame: Baseline (preoperative) and postoperative day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 30304509Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.
- Background: PubMed 21357311Ludwig C, Angenendt S, Martins R, Mayer V, Stoelben E. Intermittent positive-pressure breathing after lung surgery. Asian Cardiovasc Thorac Ann. 2011 Feb;19(1):10-3. doi: 10.1177/0218492310394664.
- Background: PubMed 23429831Agostini P, Naidu B, Cieslik H, Steyn R, Rajesh PB, Bishay E, Kalkat MS, Singh S. Effectiveness of incentive spirometry in patients following thoracotomy and lung resection including those at high risk for developing pulmonary complications. Thorax. 2013 Jun;68(6):580-5. doi: 10.1136/thoraxjnl-2012-202785. Epub 2013 Feb 21.
- 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.
Shu-Hung Kuo, M.S. principal investigator
Fu Jen Catholic University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Positive Pressure Breathing and Incentive Spirometry in people with Postoperative Pulmonary Complications and Thoracic Surgery, run by Fu Jen Catholic University Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shu-Hung Kuo, M.D. (+886-2-8512-8888 ext. 23426, A05511@mail.fjuh.fju.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lung Volume (time frame: Baseline (preoperative) and postoperative day 3). The study lists 3 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 NCT07867548, which also lists 3 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 9 Oct 2026.