- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05192785
The Effects Incentive Spirometry Use in Coronary Artery Bypass Surgery
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Adana
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Sarıçam, Adana, Turkey (Türkiye)
- Çukurova University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Participants 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.
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Experimental: Incentive Spirometry Group
Participants 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Partial Pressure of Oxygen (PaO2)
Time Frame: Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3
|
Measurement of the partial pressure of oxygen (mmHg) obtained via arterial blood gas analysis to evaluate oxygenation levels.
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Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3
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Partial Pressure of Carbon Dioxide (PaCO2)
Time Frame: Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3.
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Measurement of the partial pressure of carbon dioxide (mmHg) obtained via arterial blood gas analysis to evaluate ventilation efficiency.
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Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3.
|
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Arterial Oxygen Saturation (SaO2)
Time Frame: Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3.
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Measurement of the arterial oxygen saturation percentage (%) obtained via arterial blood gas analysis.
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Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3.
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Peripheral Oxygen Saturation (SpO2)
Time Frame: Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3.
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Measurement of the peripheral oxygen saturation percentage (%) using a non-invasive pulse oximetry device.
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Preoperative, postoperative day 1, postoperative day 2, and postoperative day 3.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Systolic Blood Pressure
Time Frame: Preoperative, postoperative day 1, postoperative day 2, postoperative day 3
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Measurement of systolic blood pressure (mmHg) during the resting period to evaluate hemodynamic stability.
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Preoperative, postoperative day 1, postoperative day 2, postoperative day 3
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Change in Diastolic Blood Pressure
Time Frame: Preoperative, postoperative day 1, postoperative day 2, postoperative day 3.
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Measurement of diastolic blood pressure (mmHg) during the resting period to evaluate hemodynamic stability.
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Preoperative, postoperative day 1, postoperative day 2, postoperative day 3.
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Change in Respiratory Rate
Time Frame: Preoperative, postoperative day 1, postoperative day 2, postoperative day 3.
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Measurement of the number of breaths per minute to assess respiratory effort and function.
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Preoperative, postoperative day 1, postoperative day 2, postoperative day 3.
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Change in Pulse Rate
Time Frame: Preoperative, postoperative day 1, postoperative day 2, postoperative day 3.
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Measurement of the number of heartbeats per minute to monitor cardiovascular response.
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Preoperative, postoperative day 1, postoperative day 2, postoperative day 3.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Restrepo RD, Wettstein R, Wittnebel L, Tracy M. Incentive spirometry: 2011. Respir Care. 2011 Oct;56(10):1600-4. doi: 10.4187/respcare.01471.
- 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.
- 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.
- 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.
- 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.
- 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.
- Lumb AB. Pre-operative respiratory optimisation: an expert review. Anaesthesia. 2019 Jan;74 Suppl 1:43-48. doi: 10.1111/anae.14508.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 50202081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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