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

Universitas Padjadjaran

Status: Completed

Conditions: Postoperative Pulmonary Function Impairment

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07343921

DP.04.03/D.XIV.6.5/77/2024 (Other Identifier)

IKFR-202502.01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Supervised Incentive Spirometry (SIS)

Experimental group

Description:

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.

Treatment:

Procedure: Supervised Incentive Spirometry (SIS)

Non-Supervised Incentive Spirometry (Non-SIS)

Active Comparator group

Description:

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.

Treatment:

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