Intermittent Positive Pressure Breathing Versus Incentive Spirometry After Thoracic Surgery

NCT07867548 — Not applicable, Not yet recruiting, 30 participants, Fu Jen Catholic University Hospital

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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

RegistryNCT07867548
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment30 (Estimated)
SponsorFu Jen Catholic University Hospital (Other)
ConditionsPostoperative Pulmonary Complications, Thoracic Surgery
InterventionsIntermittent Positive Pressure Breathing, Incentive Spirometry (Other)
Datesstart 2026-10-12 (estimated), primary completion 2027-07-31 (estimated), completion 2027-07-31 (estimated), first posted 2026-10-09, last updated 2026-10-09

Related Papers Related Patents Related Grants Related Experts
All trials for Postoperative Pulmonary Complications All trials for Thoracic Surgery All trials of Intermittent Positive Pressure Breathing All trials of Incentive Spirometry

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Intermittent Positive Pressure Breathing GroupExperimentalOther: 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 GroupActive comparatorOther: Incentive SpirometryParticipants assigned to this group will perform postoperative lung expansion training using incentive spirometry from postoperative day 0 through postoperative day 3.
  • Intermittent Positive Pressure Breathing (Other): Intermittent positive pressure breathing will be provided as a postoperative lung expansion intervention from postoperative day 0 through postoperative day 3.
  • Incentive Spirometry (Other): 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.

+Outcome measures

Primary outcomes

  • Change in Lung Volume [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 [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 [Baseline (preoperative) and postoperative day 3]: Change in maximal expiratory pressure (MEP) measured using a respiratory pressure measurement device to assess expiratory muscle strength.

Secondary outcomes

  • Change in C-Reactive Protein [Baseline (preoperative) and postoperative day 3]: Change in serum C-reactive protein (CRP) concentration as an indicator of postoperative inflammatory response.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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:

* 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.

+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. PMID 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. PMID 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. PMID 23429831

+Investigators