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Not yet recruitingNCT07867548Updated Oct 9, 2026

Intermittent Positive Pressure Breathing Versus Incentive Spirometry After Thoracic Surgery

An interventional study of Intermittent Positive Pressure Breathing and Incentive Spirometry in Postoperative Pulmonary Complications and Thoracic Surgery, sponsored by Fu Jen Catholic University Hospital. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by Fu Jen Catholic University Hospital · Not applicable, Interventional, and Prevention

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Postoperative Pulmonary Complications
  • Thoracic Surgery

Keywords

  • Intermittent Positive Pressure Breathing
  • Incentive Spirometry
  • Thoracic Surgery
  • Postoperative Pulmonary Complications
  • Pulmonary Rehabilitation
  • Lung Volume
  • Respiratory Muscle Strength
03

In context

Lead sponsor

Fu Jen Catholic University Hospital is the lead sponsor of 32 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Intermittent Positive Pressure Breathing Group

    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.

    Other: Intermittent Positive Pressure Breathing

  • Active comparator
    Incentive Spirometry Group

    Participants assigned to this group will perform postoperative lung expansion training using incentive spirometry from postoperative day 0 through postoperative day 3.

    Other: Incentive Spirometry

Interventions

  • OtherIntermittent Positive Pressure Breathing

    Intermittent positive pressure breathing will be provided as a postoperative lung expansion intervention from postoperative day 0 through postoperative day 3.

  • OtherIncentive Spirometry

    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.

06

What researchers measure

Primary outcomes

  1. Change in Lung Volume

    Change in lung volume, including tidal volume and minute ventilation, measured using a respiratory volume measurement device.

    Time frame: Baseline (preoperative) and postoperative day 3

  2. Change in Maximal Inspiratory Pressure

    Change in maximal inspiratory pressure (MIP) measured using a respiratory pressure measurement device to assess inspiratory muscle strength.

    Time frame: Baseline (preoperative) and postoperative day 3

  3. Change in Maximal Expiratory Pressure

    Change in maximal expiratory pressure (MEP) measured using a respiratory pressure measurement device to assess expiratory muscle strength.

    Time frame: 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.

    Time frame: Baseline (preoperative) and postoperative day 3

07

Study locations

No study locations are listed for this record.

08

References and documents

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 30304509 ↗
  • Ludwig 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 21357311 ↗
  • Agostini 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 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07867548
Lead sponsor
Fu Jen Catholic University Hospital
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Oct 12, 2026 (estimated)
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Oct 9, 2026

Study contacts

Shu-Hung Kuo, M.D.
Contact
A05511@mail.fjuh.fju.edu.tw
+886-2-8512-8888 ext. 23426
Hui-Wen Hsu, M.S.
Contact
76wwocat@gmail.com
+886-2-8512-8888 ext. 23426
Shu-Hung Kuo, M.S.
principal investigator · Fu Jen Catholic University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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