A cross-sectional study on the impact of bedside echocardiography in critically ill pediatric patient’s management in the pediatric intensive care unit

Aim

This study aims to evaluate the impact of bedside echocardiography on the management and outcomes of critically ill pediatric patients in a Pediatric Intensive Care Unit (PICU).

Objectives

Study design

This study will employ a cross-sectional design to assess the impact of bedside echocardiography on the management of critically ill pediatric patients in a Pediatric Intensive Care Unit (PICU).

Study population

The study population will consist of critically ill pediatric patients aged one month to 18 years admitted to the PICU at Acharya Vinoba Bhave Rural Hospital, associated with Jawaharlal Nehru Medical College, Maharashtra, India, between July 2022 and July 2024.

Place of study

The study will be conducted at the Pediatric Intensive Care Unit (PICU) of Acharya Vinoba Bhave Rural Hospital, a tertiary care center in Maharashtra, India.

Inclusion criteria

Exclusion criteria

Bias

To minimize bias, the study will adhere to rigorous methodologies. Patient selection will be based on explicit inclusion and exclusion criteria, and data collection will follow standardized procedures. Researchers involved in data collection will be trained to minimize observer bias and patient anonymity will be maintained to reduce reporting bias.

Enrollment

Enrollment will be initiated after obtaining informed consent from the parents or legal guardians of eligible pediatric patients admitted to the PICU. The enrollment process will involve obtaining consent, confirming the eligibility criteria, and documenting patient demographics.

Sample size calculation

Formula

Prevalence of patients who underwent echocardiographic evaluation = 35.4%.

P =35.4% (As per reference article⁵)

Minimum sample size required 88.

Data collection

The data collection process for this study will be comprehensive and meticulously conducted to ensure the accuracy and reliability of the gathered information. This process will involve several steps and methods.

Upon admission to the PICU, critically ill pediatric patients meeting the inclusion criteria will be identified. Informed consent will be obtained from their parents or legal guardians before commencing the data collection procedures, ensuring full compliance with ethical standards.

Once consent is obtained, patient demographics including age, sex, and clinical history will be recorded by using data collection proforma. This will provide a baseline understanding of the patient population. Subsequently, a team of experienced pediatric cardiologists will conduct echocardiographic assessments of the enrolled patients. Echocardiographic evaluations will include parameters such as ejection fraction, fractional shortening, and systolic and diastolic cardiac function assessments. These assessments will be performed according to the clinical necessity, and the findings will be thoroughly documented.

In addition to echocardiographic data, relevant clinical information will be collected and recorded, including vital signs on admission, complaints, initial diagnosis, final diagnosis, type of ventilation, length of PICU stay, and the Pediatric Risk of Mortality (PRISM) score.⁷

The necessity for echocardiography will be assessed based on clinical indications, which include a variety of factors, such as the presence of cardiac murmurs, suspected cardiac diseases, hypotension or shock, hypertension, arrhythmia, signs of congestive heart failure, and several other clinical situations. Therapeutic interventions following echocardiography, such as changes in fluid management, vasopressor therapy, antihypertensive therapy, and cardiac surgery, will also be meticulously recorded.

To maintain data accuracy and quality control, research personnel involved in data collection will receive training in standardized data collection procedures. Patient confidentiality will be strictly maintained throughout the process.

Statistical methods

Descriptive statistical analysis will summarize the data, including the mean, standard deviation, median, interquartile range, and percentages. Parametric or non-parametric statistical tests, such as chi-square, Fisher’s exact test, independent t-test, Spearman’s rank correlation coefficient, or Pearson’s correlation coefficient, will assess the relationships between variables. Statistical significance will be set at P < 0.05. Data analysis will be conducted using the appropriate statistical software, R Studio version 2023.03.0-daily+82. pro2.

Ethical considerations

The Institutional Ethics Committee of the Datta Meghe Institute of Higher Education and Research (DU) has granted its approval to the study protocol (Reference number: DMIMS (DU)/IEC/2022/1073) Date: 27/06/2022. Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives.

Dissemination

After completion of the study, we will publish it in an indexed journal or conference.

Study status

The study has not yet started. After the publication of the protocol, we will begin recruitment for the study.

Importance of the study

Using bedside echocardiography in pediatric intensive care is paramount. Critically ill pediatric patients often present with complex and rapidly evolving cardiac issues, and timely and accurate assessment is crucial for their management. This study addresses the pressing need to evaluate the role of echocardiography in pediatric intensive care, particularly in a rural healthcare setting.⁸

Diagnostic value of bedside echocardiography

Bedside echocardiography can potentially transform the diagnosis and management of cardiac conditions in critically ill children. Providing real-time information on cardiac anatomy, function, and hemodynamics enables clinicians to rapidly make informed decisions. This study aims to shed light on the diagnostic value of echocardiography, including its indications, necessity, and the extent to which it correlates with clinical interventions.⁹

Enhancing patient outcomes

The primary aim of this study is to correlate the cardiac functional or structural abnormalities identified through echocardiography with pediatric outcomes. This aspect of the research is critical, as it can elucidate whether echocardiography significantly improves patient outcomes in the PICU. If it demonstrates a positive impact, it could lead to a more widespread adoption of this diagnostic tool.¹⁰

Rural healthcare setting

A unique aspect of this study is its location in a rural healthcare setting. Rural areas often require more resources and access to advanced medical technology. Assessing the applicability and effectiveness of bedside echocardiography in such a setting is particularly relevant and could provide insights directly applicable to similar healthcare environments worldwide.¹¹

Clinical decision-making

This study will also explore how echocardiography influences clinical decision-making. This includes assessing whether echocardiographic findings lead to changes in therapeutic interventions such as medication adjustments or surgical procedures. Understanding its impact on clinical decisions is essential for determining the practical value of echocardiography in the PICU.¹²

Future implications

The findings of this study are expected to have implications for clinical practice, healthcare policies, and further research. Positive results may encourage healthcare facilities in rural areas to invest in echocardiographic equipment and training, potentially leading to improved outcomes. Additionally, the study may stimulate further research into optimizing echocardiography protocols and expanding their use in pediatric critical care.

Limitations

It is important to acknowledge the potential limitations of this study. Cross-sectional studies provide valuable insights into prevalence and associations but do not establish causality. Additionally, the findings of this study may be influenced by various factors, such as the experience of the healthcare team and availability of resources.