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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Cukurova University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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).

Conditions

• Incentive Spirometry
• Oxygen Saturation

Interventions

Type	Name	Description
DEVICE	Incentive Spirometry Group	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.

Timeline

• Start date: 2021-02-15
• Primary completion: 2022-02-15
• Completion: 2022-12-15
• First posted: 2022-01-14
• Last updated: 2026-03-17

Locations

1 site across 1 country: Turkey (Türkiye)