The Effects Incentive Spirometry Use in Coronary Artery Bypass Surgery

Çukurova University

Status: Completed

Conditions: Oxygen Saturation; Incentive Spirometry

Treatments: Procedure: Incentive Spirometry Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05192785

50202081

Details and patient eligibility

About

Aims and objectives: The aims of this study is to determine the effect of incentive spirometry on arterial blood gas and venous oxygen saturation and vital signs, in addition to pulmonary rehabilitation care before and after coronary artery bypass graft surgery. The objectives; were to accelerate the healing process by reducing pulmonary complications.

Background: Nurses, who carry much of the responsibility for the basic care of patients surgery play a highly important role. As a result of strong care, the recovery process of the patients will be accelerated, the hospitalization period will be shortened and morbidity and mortality will be prevented.

Design and Methods: Included in this randomized controlled study were 32 patients who underwent coronary arterial bypass graft surgery (16 in experimental group; 16 in control group) in a university hospital. Incentive spirometry is applied in the study along with an identified inspiration technique and an expiration technique that has not been previously encountered in literature. The preoperative measured values of the patients were compared with the arterial blood gas and venous oxygen saturation values and vital signs on the first, second and third postoperative days. In this study, the CONSORT checklist was followed.

Full description

METHODS Design The patients in this dual-group, quasi-experimental randomized controlled study were divided into control and experimental groups using a block randomization method.

Study sample This study consisted of 32 patients (16 in the experimental group; 16 in the study group) who were hospitalized in the cardiovascular surgery clinic of a university hospital and underwent Coronary Artery Bypass Graft (CABG) surgery between December 2019 and February 2020. As a result of the power analysis using the G*Power 3.0.10 program with the data obtained from the research; the power of the study was found to be 85% for f=0.2251 effect size, 5% margin of error and n=32 sample number.

Data collection "Personal Information" and "Application Information" forms prepared by the researcher were used for the collection of data. The Personal Information Form (PIF) was prepared by the researcher after a review of previous studies, and included questions about age, body mass index (BMI), gender, chronic disease, alcohol and cigarette use, physical exercise, diet and American Society of Anesthesiologists (ASA) classification. The last preoperative arterial blood gas value, the values from the first, second and third postoperative days, as well as the venous oxygen saturation values and vital signs, were recorded on the application information form. Written informed consent was obtained from all the patients after they were explained the purpose of the study, and all took part in face-to-face interviews for the garnering of data.

Incentive Spirometry (IS) is designed to mimic the natural sighing or yawning maneuvers. The technique was used with a deep inspiration focus, as described previously in literature. Unlike in previous studies, IS was used in the present study not only for inspiration but also for expiration. In normal use, IS involves the raising of three balls side by side in transparent plastic tubes during each deep inspiration, but when turned upside down, the device can be applied also to expiration. It is thus possible to use the IS with both inspiration and expiration techniques, with positive effects on the patient in both uses. The present study made use of flow-focused IS with both the inspiration and expiration techniques, in addition to such routine clinical procedures as breathing exercises, coughing exercises, early mobilization and pain control.

The ethical aspect of the study Ethics committee approval (Date: 28.12.2017 Reference Number: 72 Decision Number: 8) was granted by the Non-Invasive Clinical Research Ethics Committee and the necessary institutional permissions were obtained from the hospital in which the research was conducted. The study was carried out in compliance with the principles of the Declaration of Helsinki, as revised in 2008. The patients included in the study were informed about the study, the aim of the study was explained, and their verbal and written consent for participation in the study was obtained.

Statistical analysis The Statistical Package for the Social Sciences (SPSS) Statistics (Version 24.0) package program was used for the statistical analyses. Frequency tables and descriptive statistics were used for the interpretation of the findings. Parametric methods were used for measurement values with a normal distribution. In accordance with parametric methods, the measurement values of two independent groups were compared with an Independent Sample t test (t-table value) and the measurement values of three or more dependent groups were compared with a Repeated Measures test (F-table value). Non-parametric methods were used for normally distributed measurement values. In accordance with non-parametric methods, the measurement values of two independent groups were compared with a Mann-Whitney U test (Z-table value) and the measurement values of three or more dependent groups were compared with a Friedman test (χ2-table value). Pearson-χ2 crossbars were used for the examination of the relationships between two qualitative variables. Consolidated Standards of Reporting Trials (CONSORT) checklist, guidelines for reporting of randomized controlled trials were used as the reporting guideline for this study.

Enrollment: 32 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• willing participants who could communicate
• with a stable clinical condition
• between 18 and 88 years old
• with no hearing problems
• with no previous psychiatric or mental illness
• undergoing coronary artery bypass surgery for the first time (non-emergency surgery)

Exclusion criteria

• unstable clinical situation
• declined to participate,
• history of Chronic Obstructive Pulmonary Disease (COPD) or Chronic Kidney Failure (CKD)
• those with post-operative cognitive and neurological complications and severe hemodynamic dysfunction
• those requiring resternotomy or prolonged mechanical ventilation (more than 24 hours)
• with complications (pneumonia, atelectasis , pleural effusion, etc.).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Control group

No Intervention group

Description:

In the control group, patients who met the sampling criteria filled out the Consent and Information Forms with the researcher, and the breathing and coughing exercises, and early mobilization and pain control practices that were part of the routine clinical procedure were continued. Arterial and venous oxygen saturation values and vital signs were measured and recorded at the end of the first, second and third postoperative days on the Application Information form. The researchers and clinic nurses were responsible for the execution of applications and the follow-up and monitoring of the pulmonary rehabilitation care throughout the hospitalization of the patient.

Incentive Spirometry Group

Experimental group

Description:

The patients who met the sampling criteria were given consent and information forms in the preoperative period from their admission to the clinic by the researcher and the incentive spirometry (IS) application along with respiratory and cough exercises was explained, demonstrated and performed. In addition, all postoperative patients underwent a pain assessment using the visual analogue scale (VAS) pain scale every 4-6 hours every day prior to incentive spirometry implementation, and pain control was provided based on the results (with paracetamol and opioids in the clinical routine). The patients whose pain levels were moderate and low continued the incentive spirometry application. Arterial and venous oxygen saturation values and vital signs were measured and recorded at the end of the first, second and third days postoperatively on the Application Information form.

Treatment:

Procedure: Incentive Spirometry Group