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Clinical Trials/NCT07343921
NCT07343921CompletedNot Applicable

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

Universitas Padjadjaran1 site in 1 country38 target enrollmentStarted: July 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
38
Locations
1
Primary Endpoint
Forced Expiratory Volume in 1 Second (FEV1)

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Non-Supervised Incentive Spirometry (Non-SIS)

Active Comparator

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.

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

Supervised Incentive Spirometry (SIS)

Experimental

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.

Intervention: Supervised Incentive Spirometry (SIS) (Procedure)

Outcomes

Primary Outcomes

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

  • Forced Vital Capacity (FVC)(T1 (24 hours post-extubation) and T2 (after 3 days of incentive spirometry exercise))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Arnengsih Nazir

Principal Investigator

Universitas Padjadjaran

Study Sites (1)

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