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Not yet recruitingNCT07867548ClinicalTrials.gov record

Intermittent Positive Pressure Breathing Versus Incentive Spirometry After Thoracic Surgery

Postoperative Pulmonary Complications · Thoracic Surgery

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Accepted
Participants
30 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Eligibility Criteria

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.
Understand screening

Treatment, groups and participation

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Assignment
Random assignment
Masking
No masking
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

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

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

Secondary measures

Change in C-Reactive Protein

Time frame: Baseline (preoperative) and postoperative day 3

Change in serum C-reactive protein (CRP) concentration as an indicator of postoperative inflammatory response.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (0)

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No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor
Fu Jen Catholic University Hospital
Study start
Oct 12, 2026 Estimated
Primary completion
Jul 31, 2027 Estimated
Study completion
Jul 31, 2027 Estimated
First posted
Oct 9, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Official study 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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026