Clinical Trials Directory

Trials / Completed

CompletedNCT07343921

Supervised vs Non-Supervised Incentive Spirometry After CABG

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
38 (actual)
Sponsor
Universitas Padjadjaran · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESupervised 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.
PROCEDURENon-Supervised Incentive Spirometry (Non-SIS)Exercises independently using a guideline form with daily reminders. Participants log activity. 6 sets of 5 breaths per session.

Timeline

Start date
2024-07-01
Primary completion
2024-12-01
Completion
2025-01-01
First posted
2026-01-15
Last updated
2026-01-15

Locations

1 site across 1 country: Indonesia

Source: ClinicalTrials.gov record NCT07343921. Inclusion in this directory is not an endorsement.