The Effects Incentive Spirometry Use in Coronary Artery Bypass Surgery

NCT05192785 | Completed

• 1 other identifier: 50202081
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Incentive Spirometry; Oxygen Saturation

Keywords

Vital Signs; Coronary Heart Disease; Post-operative Care; Practice Nursing; Respiratory Nursing; Surgical Nursing

Outcome Measures

Primary Outcomes (4)

• Partial Pressure of Oxygen (PaO2)

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

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

• 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.

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

• Arterial Oxygen Saturation (SaO2)

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

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

• Peripheral Oxygen Saturation (SpO2)

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

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

Secondary Outcomes (4)

• Change in Systolic Blood Pressure

  Preoperative, postoperative day 1, postoperative day 2, postoperative day 3

• Change in Diastolic Blood Pressure

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

• Change in Respiratory Rate

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

• Change in Pulse Rate

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

Study Arms (2)

Control group

NO INTERVENTION

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.

Incentive Spirometry Group

EXPERIMENTAL

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.

Device: Incentive Spirometry Group

Interventions

Incentive Spirometry Group DEVICE

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.

Incentive Spirometry Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Sarıçam, Adana, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 18039692 BACKGROUND

• 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.

  PMID: 29367198 BACKGROUND

• 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.

  PMID: 22002191 BACKGROUND

• 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.

  PMID: 30969332 BACKGROUND

• 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.

  PMID: 29279365 BACKGROUND

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

  PMID: 30604419 BACKGROUND

• 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.

  PMID: 31291879 BACKGROUND

• 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.

  PMID: 28097332 BACKGROUND

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

  PMID: 22008401 BACKGROUND

• 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.

  PMID: 19627688 RESULT

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (MSc)

Model Details: 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).

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 14, 2022
• Study Start: February 15, 2021
• Primary Completion: February 15, 2022
• Study Completion: December 15, 2022
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)