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Completed

NCT Number: NCT07343921

Supervised vs Non-Supervised Incentive Spirometry After CABG

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSUP Dr. Hasan Sadikin

Bandung, West Java, 40161, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised Incentive Spirometry (SIS)

Procedure

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.

Non-Supervised Incentive Spirometry (Non-SIS)

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

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

Acronym: SIS-CABG

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.