NCT07343921

Brief Summary

This study aims to evaluate the effect of supervised incentive spirometry (SIS) compared to unsupervised incentive spirometry (Non-SIS) on pulmonary function in patients following coronary artery bypass graft (CABG) surgery. Participants perform incentive spirometry exercises twice daily for three days after extubation. Pulmonary function parameters, including forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF), are assessed before and after the intervention period to compare changes between the two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

December 19, 2025

Last Update Submit

January 6, 2026

Conditions

Keywords

CABGincentive spirometrypulmonary functionsupervisionpostoperative care

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume in 1 Second (FEV1)

    Measures the volume of air that can be forcibly exhaled in one second to assess pulmonary function in post-CABG patients.

    T1 (24 hours post-extubation) and T2 (after 3 days of incentive spirometry exercise)

Secondary Outcomes (1)

  • Forced Vital Capacity (FVC)

    T1 (24 hours post-extubation) and T2 (after 3 days of incentive spirometry exercise)

Other Outcomes (1)

  • Peak Expiratory Flow (PEF)

    T1 (24 hours post-extubation) and T2 (after 3 days of incentive spirometry exercise)

Study Arms (2)

Supervised Incentive Spirometry (SIS)

EXPERIMENTAL

Participants perform incentive spirometry exercises twice daily for 3 days under direct supervision. The supervisor observes the technique, provides corrections, answers questions, and ensures adherence to the prescribed exercise regimen.

Procedure: Supervised Incentive Spirometry (SIS)

Non-Supervised Incentive Spirometry (Non-SIS)

ACTIVE COMPARATOR

Participants perform incentive spirometry exercises independently using a provided guideline form. Supervisors provide daily reminders but do not directly observe the exercises. Participants log their activity daily.

Procedure: Non-Supervised Incentive Spirometry (Non-SIS)

Interventions

Participants perform incentive spirometry exercises twice daily for 3 days under direct supervision. The supervisor monitors technique, corrects errors, answers questions, and ensures exercises are done accurately. Each session includes 6 sets of 5 breaths, with slow inhalation, 2-second breath-hold, and slow exhalation, separated by rest periods. This intervention is performed in addition to standard cardiac rehabilitation.

Supervised Incentive Spirometry (SIS)

Exercises independently using a guideline form with daily reminders. Participants log activity. 6 sets of 5 breaths per session.

Non-Supervised Incentive Spirometry (Non-SIS)

Eligibility Criteria

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

You may qualify if:

  • Adult patients aged ≥18 years.
  • Patients who have undergone Coronary Artery Bypass Graft (CABG) surgery.
  • Mechanical ventilation \<24 hours post-surgery.
  • Physically able to perform incentive spirometry (IS) exercises.
  • Signed informed consent to participate in the study.

You may not qualify if:

  • Hemodynamically unstable patients.
  • Patients with cognitive or communication impairments.
  • Oral abnormalities that prevent the use of IS.
  • Patients with Chronic Obstructive Pulmonary Disease (COPD).
  • Patients with thoracic anomalies.
  • Patients who required reintubation.
  • History of incentive spirometry use within the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUP Dr. Hasan Sadikin

Bandung, West Java, 40161, Indonesia

Location

Related Publications (5)

  • Ababneh QM, Abdelrahman H, Abdelhameed ME. Effectiveness of Incentive Spirometry Versus Deep Breathing Exercises in Preventing Postoperative Pulmonary Complications After Abdominal Surgery: A Comprehensive Review. Cureus. 2025 Mar 6;17(3):e80149. doi: 10.7759/cureus.80149. eCollection 2025 Mar.

  • do Nascimento Junior P, Modolo NS, Andrade S, Guimaraes MM, Braz LG, El Dib R. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2014 Feb 8;2014(2):CD006058. doi: 10.1002/14651858.CD006058.pub3.

  • Alwekhyan SA, Alshraideh JA, Yousef KM, Hayajneh F. Nurse-guided incentive spirometry use and postoperative pulmonary complications among cardiac surgery patients: A randomized controlled trial. Int J Nurs Pract. 2022 Apr;28(2):e13023. doi: 10.1111/ijn.13023. Epub 2021 Oct 22.

  • Su H, Zhang J, Liu Y, Peng H, Zhang L. Pre and postoperative nurse-guided incentive spirometry versus physiotherapist-guided pre and postoperative breathing exercises in patients undergoing cardiac surgery: An evaluation of postoperative complications and length of hospital stay. Medicine (Baltimore). 2022 Dec 30;101(52):e32443. doi: 10.1097/MD.0000000000032443.

  • Melly L, Torregrossa G, Lee T, Jansens JL, Puskas JD. Fifty years of coronary artery bypass grafting. J Thorac Dis. 2018 Mar;10(3):1960-1967. doi: 10.21037/jtd.2018.02.43.

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 15, 2026

Study Start

July 1, 2024

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations