Supervised vs Non-Supervised Incentive Spirometry After CABG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-01-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Postoperative Pulmonary Function Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Supervised Incentive Spirometry (SIS)

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

Non-Supervised Incentive Spirometry (Non-SIS)

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No