Clinical trial NCT05192785: The Effects Incentive Spirometry Use in Coronary Artery Bypass Surgery
Official title: The Effects on Arterial Blood Gas, Venous Oxygen Saturation and Vital Findings of Incentive Spirometry Use With Inspiration and Expiration Techniques in Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incentive Spirometry
Oxygen Saturation
Keywords: Vital Signs
Coronary Heart Disease
Post-operative Care
Practice Nursing
Respiratory Nursing
Surgical Nursing
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Change from arterial blood gas parameters at 4 days
timeFrame: Preop, Postop 1.day, Postop 2.day, Postop 3.day
measure: Change from venous oxygen saturation parameters at 4 days
timeFrame: Preop, Postop 1.day, Postop 2.day, Postop 3.day
measure: Vital signs- Change from systolic and diastolic blood pressure at 4 days (mmHg)
timeFrame: Preop, Postop 1.day, Postop 2.day, Postop 3.day
measure: Vital signs- Change from respiratory rate per minute at 4 days
timeFrame: Preop, Postop 1.day, Postop 2.day, Postop 3.day
measure: Vital signs- Change from heart rate per minute at 4 days
timeFrame: Preop, Postop 1.day, Postop 2.day, Postop 3.day
Secondary outcomes:
Other outcomes:
Locations:
city: Sarıçam
country: Turkey
facility: Cukurova University
state: Adana
Study officials:
References:
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