Postoperative Pulmonary Function ImpairmentSIS-CABGNCT07343921
Supervised vs Non-Supervised Incentive Spirometry After CABG
A study testing Supervised Incentive Spirometry (SIS) and Non-Supervised Incentive Spirometry (Non-SIS) in people with Postoperative Pulmonary Function Impairment, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Function Impairment
- What is being tested?
- Supervised Incentive Spirometry (SIS) and Non-Supervised Incentive Spirometry (Non-SIS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Lung Function in Post-CABG Patients Administered Supervised and Non-supervised Post-operative Incentive Spirometry: a Quasi-experimental Study
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.
Read the 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.
- Being tested
- Supervised Incentive Spirometry (SIS), Non-Supervised Incentive Spirometry (Non-SIS)
- Keywords
- CABG, incentive spirometry, pulmonary function, supervision, postoperative care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Incentive Spirometry (SIS)Procedure or surgery
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 or surgery
Exercises independently using a guideline form with daily reminders. Participants log activity. 6 sets of 5 breaths per session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Supervised Incentive Spirometry (SIS) |
| 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. Receives: Procedure: Non-Supervised Incentive Spirometry (Non-SIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 Second (FEV1)
Measures the volume of air that can be forcibly exhaled in one second to assess pulmonary function in post-CABG patients.
Measured: T1 (24 hours post-extubation) and T2 (after 3 days of incentive spirometry exercise)
Secondary outcomes (1)
Forced Vital Capacity (FVC)
Measures the total volume of air that can be exhaled after a maximal inhalation to evaluate restrictive ventilatory patterns in post-CABG patients.
Measured: T1 (24 hours post-extubation) and T2 (after 3 days of incentive spirometry exercise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jul 2024
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary Function ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnengsih Nazir, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343921
- Sponsor's protocol ID
- IKFR-202502.01
- Other IDs
- DP.04.03/D.XIV.6.5/77/2024
- Acronym
- SIS-CABG
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ababneh QM, Abdelrahman H, Abdelhameed ME. Effectiveness of Incentive Spirometry Versus Deep Breathing Exercises in Preventing Postoperative Pulmonary Complications After Abdominal Surgery: A Comprehensive Review. Cureus. 2025 Mar 6;17(3):e80149. doi: 10.7759/cureus.80149. eCollection 2025 Mar.
PubMed 40190855do Nascimento Junior P, Modolo NS, Andrade S, Guimaraes MM, Braz LG, El Dib R. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2014 Feb 8;2014(2):CD006058. doi: 10.1002/14651858.CD006058.pub3.
PubMed 24510642Alwekhyan SA, Alshraideh JA, Yousef KM, Hayajneh F. Nurse-guided incentive spirometry use and postoperative pulmonary complications among cardiac surgery patients: A randomized controlled trial. Int J Nurs Pract. 2022 Apr;28(2):e13023. doi: 10.1111/ijn.13023. Epub 2021 Oct 22.
PubMed 34676618Su H, Zhang J, Liu Y, Peng H, Zhang L. Pre and postoperative nurse-guided incentive spirometry versus physiotherapist-guided pre and postoperative breathing exercises in patients undergoing cardiac surgery: An evaluation of postoperative complications and length of hospital stay. Medicine (Baltimore). 2022 Dec 30;101(52):e32443. doi: 10.1097/MD.0000000000032443.
PubMed 36596066Melly L, Torregrossa G, Lee T, Jansens JL, Puskas JD. Fifty years of coronary artery bypass grafting. J Thorac Dis. 2018 Mar;10(3):1960-1967. doi: 10.21037/jtd.2018.02.43.
PubMed 29707352
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lung Function in Post-CABG Patients Administered Supervised and Non-supervised Post-operative Incentive Spirometry: a Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT07343921
- Acronym / sponsor ID
- SIS-CABG / IKFR-202502.01
- Keywords
- CABG, incentive spirometry, pulmonary function, supervision, postoperative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Incentive Spirometry (SIS) | Experimental | Procedure: 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. |
| Non-Supervised Incentive Spirometry (Non-SIS) | Active comparator | Procedure: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Supervised Incentive Spirometry (SIS) |
| 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. | Procedure or surgery | Non-Supervised Incentive Spirometry (Non-SIS) |
Primary outcome
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.
1 secondary outcome
Forced Vital Capacity (FVC)
Time frame: T1 (24 hours post-extubation) and T2 (after 3 days of incentive spirometry exercise)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Results publication: PubMed 40190855Ababneh QM, Abdelrahman H, Abdelhameed ME. Effectiveness of Incentive Spirometry Versus Deep Breathing Exercises in Preventing Postoperative Pulmonary Complications After Abdominal Surgery: A Comprehensive Review. Cureus. 2025 Mar 6;17(3):e80149. doi: 10.7759/cureus.80149. eCollection 2025 Mar.
- Results publication: PubMed 24510642do Nascimento Junior P, Modolo NS, Andrade S, Guimaraes MM, Braz LG, El Dib R. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2014 Feb 8;2014(2):CD006058. doi: 10.1002/14651858.CD006058.pub3.
- Results publication: PubMed 34676618Alwekhyan SA, Alshraideh JA, Yousef KM, Hayajneh F. Nurse-guided incentive spirometry use and postoperative pulmonary complications among cardiac surgery patients: A randomized controlled trial. Int J Nurs Pract. 2022 Apr;28(2):e13023. doi: 10.1111/ijn.13023. Epub 2021 Oct 22.
- Results publication: PubMed 36596066Su H, Zhang J, Liu Y, Peng H, Zhang L. Pre and postoperative nurse-guided incentive spirometry versus physiotherapist-guided pre and postoperative breathing exercises in patients undergoing cardiac surgery: An evaluation of postoperative complications and length of hospital stay. Medicine (Baltimore). 2022 Dec 30;101(52):e32443. doi: 10.1097/MD.0000000000032443.
- Results publication: PubMed 29707352Melly L, Torregrossa G, Lee T, Jansens JL, Puskas JD. Fifty years of coronary artery bypass grafting. J Thorac Dis. 2018 Mar;10(3):1960-1967. doi: 10.21037/jtd.2018.02.43.
- Melly L, Torregrossa G, Lee T, Jansens JL, Puskas JD. Fifty years of coronary artery bypass grafting. J Thorac Dis. 2018;10(3):1960-7.Link provided by the sponsor.
- Su H, Zhang J, Liu Y, Peng H, Zhang L. Pre and postoperative nurse-guided incentive spirometry vs. physiotherapist-guided breathing exercises in cardiac surgery. Medicine (Baltimore). 2022;101(52):e32443.Link provided by the sponsor.
- Saja Ahmad Alwekhyan et al. Nurse-guided incentive spirometry use and postoperative pulmonary complications among cardiac surgery patients. Int J Nurs Pract. 2022;28(2):e13023.Link provided by the sponsor.
- do Nascimento Junior P, Módolo NS, Andrade S, Guimarães MM, Braz LG, El Dib R. Incentive spirometry for prevention of postoperative pulmonary complications in upper abdominal surgery. Cochrane Database Syst Rev. 2014;(2):CD006058.pub3.Link provided by the sponsor.
- Ababneh QM et al. Effectiveness of Incentive Spirometry Versus Deep Breathing Exercises in Preventing Postoperative Pulmonary Complications After Abdominal Surgery: A Comprehensive Review. Cureus. 2025;17(3):e80149.Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Incentive Spirometry (SIS) and Non-Supervised Incentive Spirometry (Non-SIS) in people with Postoperative Pulmonary Function Impairment, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Expiratory Volume in 1 Second (FEV1) (time frame: T1 (24 hours post-extubation) and T2 (after 3 days of incentive spirometry exercise)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07343921, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.