Supervised vs Non-Supervised Incentive Spirometry After CABG (SIS-CABG)

January 6, 2026 updated by: Arnengsih Nazir, Universitas Padjadjaran

Comparison of Lung Function in Post-CABG Patients Administered Supervised and Non-supervised Post-operative Incentive Spirometry: a Quasi-experimental Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Coronary artery bypass graft (CABG) surgery is associated with an increased risk of postoperative pulmonary complications, such as atelectasis, pneumonia, and pleural effusion, which may impair pulmonary function. Incentive spirometry (IS) is commonly used as part of postoperative care to promote deep breathing, enhance alveolar recruitment, and improve lung volumes.

This quasi-experimental study is conducted at Dr. Hasan Sadikin General Hospital, Bandung, Indonesia, and enrolls patients who have undergone CABG surgery. Participants are consecutively assigned to one of two intervention groups: supervised incentive spirometry (SIS) or unsupervised incentive spirometry (Non-SIS).

Participants in the SIS group perform incentive spirometry exercises under direct supervision by healthcare personnel twice daily to ensure correct technique and adherence. Participants in the Non-SIS group perform the same exercises independently with routine reminders. Both groups receive a standardized postoperative cardiac rehabilitation program.

Pulmonary function is assessed using a portable spirometer measuring forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF). Measurements are conducted at 24 hours post-extubation (T1) and after three days of incentive spirometry exercises (T2). The primary objective is to compare changes in pulmonary function parameters between the supervised and unsupervised groups.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia, 40161
        • RSUP Dr. Hasan Sadikin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supervised Incentive Spirometry (SIS)
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)
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.
Active Comparator: Non-Supervised Incentive Spirometry (Non-SIS)
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)
Exercises independently using a guideline form with daily reminders. Participants log activity. 6 sets of 5 breaths per session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: T1 (24 hours post-extubation) and T2 (after 3 days of incentive spirometry exercise)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity (FVC)
Time Frame: T1 (24 hours post-extubation) and T2 (after 3 days of incentive spirometry exercise)
Measures the total volume of air that can be exhaled after a maximal inhalation to evaluate restrictive ventilatory patterns in post-CABG patients.
T1 (24 hours post-extubation) and T2 (after 3 days of incentive spirometry exercise)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Expiratory Flow (PEF)
Time Frame: T1 (24 hours post-extubation) and T2 (after 3 days of incentive spirometry exercise)
Measures the maximal airflow during forced exhalation to assess the ability of the lungs to expel air in post-CABG patients.
T1 (24 hours post-extubation) and T2 (after 3 days of incentive spirometry exercise)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IKFR-202502.01
  • DP.04.03/D.XIV.6.5/77/2024 (Other Identifier: Komite Etik Penelitian RSUP Dr. Hasan Sadikin Bandung)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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