NCT07867548

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Oct 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

October 12, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

10 months

First QC Date

October 5, 2026

Last Update Submit

October 5, 2026

Conditions

Keywords

Intermittent Positive Pressure BreathingIncentive SpirometryThoracic SurgeryPostoperative Pulmonary ComplicationsPulmonary RehabilitationLung VolumeRespiratory Muscle Strength

Outcome Measures

Primary Outcomes (3)

  • Change in Lung Volume

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

    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.

    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.

    Baseline (preoperative) and postoperative day 3

Secondary Outcomes (1)

  • Change in C-Reactive Protein

    Baseline (preoperative) and postoperative day 3

Study Arms (2)

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.

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.

Other: Incentive Spirometry

Interventions

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

Intermittent Positive Pressure Breathing Group

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.

Incentive Spirometry Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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: 30304509BACKGROUND
  • 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: 21357311BACKGROUND
  • 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: 23429831BACKGROUND

MeSH Terms

Interventions

Intermittent Positive-Pressure Breathing

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Shu-Hung Kuo, M.S.

    Fu Jen Catholic University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in parallel to either the intermittent positive pressure breathing group or the incentive spirometry group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 9, 2026

Study Start (Estimated)

October 12, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share