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Incentive SpirometryNCT05192785

The Effects Incentive Spirometry Use in Coronary Artery Bypass Surgery

A study testing Incentive Spirometry Group in people with Incentive Spirometry and Oxygen Saturation, run by Cukurova University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Incentive spirometry is used in addition to care, especially in reducing pulmonary complications after surgery. Complications in the cardiovascular and pulmonary systems can basically be determined by blood values and vital signs, which are important objective data of haemodynamics. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Incentive Spirometry, Oxygen Saturation
What is being tested?
Incentive Spirometry Group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Feb 2021to 15 Dec 2022
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients undergoing first-time, nonemergency coronary artery bypass graft surgery
  • Patients who agreed to participate in the study
  • Patients who were able to communicate
  • Patients with no hearing difficulty
  • Patients with no history of psychiatric and/or mental illness
  • -Patients with a stable clinical condition

Who cannot join

  • Patients with an unstable clinical condition
  • Patients who refused to participate
  • Patients with chronic obstructive pulmonary disease
  • Patients with chronic kidney failure
  • Patients with severe hemodynamic dysfunction
  • Patients requiring sternotomy or re-sternotomy
  • Patients requiring prolonged mechanical ventilation

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Cukurova University

    Sarıçam, Adana

Other trials in Turkey (Türkiye)

About this study

Official title: Outcomes of Incentive Spirometry for Patients Undergoing Coronary Artery Bypass Surgery: A Randomised Controlled Trial

Background: Incentive spirometry is used in addition to care, especially in reducing pulmonary complications after surgery. Complications in the cardiovascular and pulmonary systems can basically be determined by blood values and vital signs, which are important objective data of haemodynamics.

Aim: This study was designed to test the hypothesis that the use of incentive spirometry in conjunction with postoperative pulmonary rehabilitation care has a notable impact on arterial blood gas, oxygen saturation (SpO2), and vital signs.

Methods: This randomised, controlled trial was designed using a repeated-measures design. The study was planned to be conducted at the cardiovascular surgery clinic of a university hospital. It was intended that data from patients undergoing coronary artery bypass graft surgery would be analyzed. All patients were planned to receive routine pulmonary rehabilitation, with incentive spirometry added for the experimental group. Outcome measures were designed to include arterial blood gas values, oxygen saturation, and vital signs recorded during the postoperative period.

Read the detailed description

This study was designed as a single-center, randomized controlled trial with repeated measures to evaluate the effects of incentive spirometry used in addition to routine postoperative pulmonary rehabilitation in patients undergoing coronary artery bypass graft surgery.

The study was planned to be conducted in the cardiovascular surgery clinic of a university hospital. Patients assessed for eligibility were to be randomized into two groups: an experimental group (receiving incentive spirometry plus routine pulmonary rehabilitation) or a control group (receiving routine pulmonary rehabilitation only).

Randomization was performed using a simple randomization method with a computer-generated random number table. Group assignments were placed in sequentially numbered sealed envelopes to ensure allocation concealment. A single-blind approach was used during randomization, where the principal investigator and the statistician remained blinded to group assignments.

In the experimental group, it was planned that patients would receive routine pulmonary rehabilitation together with incentive spirometry. The device intended for use was a flow-oriented incentive spirometer with three chambers (target volumes: 600, 900, and 1200 mL). The intervention was planned to be initiated postoperatively after extubation and continued throughout the hospital stay. The procedure involved 10 to 20 deep breaths every 1 to 2 hours, combined with coughing exercises.

The control group was planned to receive routine pulmonary rehabilitation care without incentive spirometry. This care included deep breathing and coughing exercises, pain assessment, and early mobilization. Early mobilization was planned for both groups.

Data collection was planned to be performed during the preoperative period and across the early postoperative period (Days 1, 2, and 3). Recorded variables were intended to include demographic characteristics, arterial blood gas values (PaO2, PaCO2, SaO2), peripheral oxygen saturation (SpO2), and vital signs (systolic/diastolic blood pressure, respiratory rate, and pulse rate).

Being tested
Incentive Spirometry Group
Keywords
Vital Signs, Coronary Heart Disease, Post-operative Care, Practice Nursing, Respiratory Nursing, Surgical Nursing
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Incentive Spirometry GroupDevice

    A flow-oriented incentive spirometer with three compartments and target volumes of 600, 900, and 1200 mL was used. Patients were instructed in its use preoperatively and continued the application after extubation when fully awake. The intervention was performed every 1 to 2 hours while awake, for a total of 10 to 20 breaths according to tolerance. Patients performed deep breathing exercises first, followed by incentive spirometry, and then coughing exercises. During the application, the bed was elevated to 45 degrees and the patient was positioned in long sitting. Patients were instructed to inhale slowly and deeply to raise the balls to the target level, hold their breath for 3 to 5 seconds, and then exhale normally. The exercise was repeated according to tolerance, and coughing exercises were performed after every five repetitions.

Study groups in NCT05192785
Study groupRoleWhat they receive
Control groupNo interventionParticipants in the control group received routine postoperative pulmonary rehabilitation care without incentive spirometry. Routine care included deep breathing exercises, coughing exercises, pain assessment and management, and early mobilization during hospitalization. Arterial blood gas parameters, peripheral oxygen saturation, and vital signs were measured and recorded during the resting period at the end of postoperative days 1, 2, and 3.
Incentive Spirometry GroupExperimentalParticipants in the experimental group received routine postoperative pulmonary rehabilitation care plus incentive spirometry. Routine care included deep breathing exercises, coughing exercises, pain assessment and management, and early mobilization during hospitalization. Incentive spirometry was explained, demonstrated, and applied preoperatively and continued after extubation when the patient was fully awake. The intervention included 10 to 20 breaths every 1 to 2 hours according to patient tolerance. Arterial blood gas parameters, peripheral oxygen saturation, and vital signs were measured and recorded during the resting period at the end of postoperative days 1, 2, and 3.
Receives: Device: Incentive Spirometry Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Partial Pressure of Oxygen (PaO2)

    Measurement of the partial pressure of oxygen (mmHg) obtained via arterial blood gas analysis to evaluate oxygenation levels.

    Measured: Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3

  2. Partial Pressure of Carbon Dioxide (PaCO2)

    Measurement of the partial pressure of carbon dioxide (mmHg) obtained via arterial blood gas analysis to evaluate ventilation efficiency.

    Measured: Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3.

  3. Arterial Oxygen Saturation (SaO2)

    Measurement of the arterial oxygen saturation percentage (%) obtained via arterial blood gas analysis.

    Measured: Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3.

  4. Peripheral Oxygen Saturation (SpO2)

    Measurement of the peripheral oxygen saturation percentage (%) using a non-invasive pulse oximetry device.

    Measured: Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3.

Secondary outcomes (4)
  1. Change in Systolic Blood Pressure

    Measurement of systolic blood pressure (mmHg) during the resting period to evaluate hemodynamic stability.

    Measured: Preoperative, postoperative day 1, postoperative day 2, postoperative day 3

  2. Change in Diastolic Blood Pressure

    Measurement of diastolic blood pressure (mmHg) during the resting period to evaluate hemodynamic stability.

    Measured: Preoperative, postoperative day 1, postoperative day 2, postoperative day 3.

  3. Change in Respiratory Rate

    Measurement of the number of breaths per minute to assess respiratory effort and function.

    Measured: Preoperative, postoperative day 1, postoperative day 2, postoperative day 3.

  4. Change in Pulse Rate

    Measurement of the number of heartbeats per minute to monitor cardiovascular response.

    Measured: Preoperative, postoperative day 1, postoperative day 2, postoperative day 3.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2022
  2. Study start15 Feb 2021
  3. Primary completion15 Feb 2022
  4. Study completion15 Dec 2022

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This research, randomised controlled design with repeated measures was used, and the patients were divided into two different groups, as the control (non-IS) and experimental (IS-Exp).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05192785
Sponsor's protocol ID
50202081
Status last verified
Mar 2026
First submitted
13 Dec 2021
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Agostini P, Calvert R, Subramanian H, Naidu B. Is incentive spirometry effective following thoracic surgery? Interact Cardiovasc Thorac Surg. 2008 Apr;7(2):297-300. doi: 10.1510/icvts.2007.171025. Epub 2007 Nov 26.

    PubMed 18039692
  • Boden I, Skinner EH, Browning L, Reeve J, Anderson L, Hill C, Robertson IK, Story D, Denehy L. Preoperative physiotherapy for the prevention of respiratory complications after upper abdominal surgery: pragmatic, double blinded, multicentre randomised controlled trial. BMJ. 2018 Jan 24;360:j5916. doi: 10.1136/bmj.j5916.

    PubMed 29367198
  • Carvalho CR, Paisani DM, Lunardi AC. Incentive spirometry in major surgeries: a systematic review. Rev Bras Fisioter. 2011 Sep-Oct;15(5):343-50. doi: 10.1590/s1413-35552011005000025. Epub 2011 Oct 14.

    PubMed 22002191
  • Eltorai AEM, Baird GL, Eltorai AS, Healey TT, Agarwal S, Ventetuolo CE, Martin TJ, Chen J, Kazemi L, Keable CA, Diaz E, Pangborn J, Fox J, Connors K, Sellke FW, Elias JA, Daniels AH. Effect of an Incentive Spirometer Patient Reminder After Coronary Artery Bypass Grafting: A Randomized Clinical Trial. JAMA Surg. 2019 Jul 1;154(7):579-588. doi: 10.1001/jamasurg.2019.0520.

    PubMed 30969332
  • Eltorai AEM, Szabo AL, Antoci V Jr, Ventetuolo CE, Elias JA, Daniels AH, Hess DR. Clinical Effectiveness of Incentive Spirometry for the Prevention of Postoperative Pulmonary Complications. Respir Care. 2018 Mar;63(3):347-352. doi: 10.4187/respcare.05679. Epub 2017 Dec 26.

    PubMed 29279365
  • Lumb AB. Pre-operative respiratory optimisation: an expert review. Anaesthesia. 2019 Jan;74 Suppl 1:43-48. doi: 10.1111/anae.14508.

    PubMed 30604419
  • Moradian ST, Heydari AA, Mahmoudi H. What is the Role of Preoperative Breathing Exercises in Reducing Postoperative Atelectasis after CABG? Rev Recent Clin Trials. 2019;14(4):275-279. doi: 10.2174/1574887114666190710165951.

    PubMed 31291879
  • Pantel H, Hwang J, Brams D, Schnelldorfer T, Nepomnayshy D. Effect of Incentive Spirometry on Postoperative Hypoxemia and Pulmonary Complications After Bariatric Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 May 1;152(5):422-428. doi: 10.1001/jamasurg.2016.4981.

    PubMed 28097332
  • Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.

    PubMed 22008401
  • Agostini P, Singh S. Incentive spirometry following thoracic surgery: what should we be doing? Physiotherapy. 2009 Jun;95(2):76-82. doi: 10.1016/j.physio.2008.11.003. Epub 2009 Mar 3.

    PubMed 19627688

Questions about this trial

What is this clinical trial studying?

A study testing Incentive Spirometry Group in people with Incentive Spirometry and Oxygen Saturation, run by Cukurova University at 1 site in Turkey (Türkiye).

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 6 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 17 Mar 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 Turkey (Türkiye). 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?

Partial Pressure of Oxygen (PaO2) (time frame: Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3). The study lists 4 primary outcomes in all. 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 NCT05192785, which also lists 10 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 17 Mar 2026.

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