Etiology, Complications & Outcome of Patients with Respiratory Illnesses Admitted to a Tertiary Care Pediatric Intensive Care Unit.

Aims & Objectives:

The aims and objectives of this study are-

Primary objectives:

For the patients admitted to a tertiary care Pediatric Intensive Care Unit (PICU) with a respiratory illness, to determine the --

1. Etiology of the respiratory illness

2. Indication for admission to the PICU

3. Final outcome (survival/death)

4. Predictors of mortality

Secondary Objectives**:**

For the patients admitted to a tertiary care Pediatric Intensive Care Unit (PICU) with a respiratory illness, to determine the --

1. Co-morbidities

2. Complications

3. Need for mechanical ventilation (non-invasive/invasive) & duration of the ventilation.

Materials & Methods:

Ethics: The study will be initiated after seeking approval from the “Institutional Ethics Committee (IEC)” of the hospital. The study will be conducted in compliance with the “Ethical Guidelines for Biomedical Research on Human Participants” by the Indian Council of Medical Research.

Consent & Assent**:**Case enrollment will be done after a written informed consent from the parent/ guardian. Since patients in the PICU are critically ill, the assent will be procured from children aged 7 years and above once the clinical condition stabilizes and when they are in a position to give the assent.

Study design: Prospective, non-interventional, observational, single centre study.

Study duration: The study will be conducted over a period of 12 months (prospectively) after approval from the IEC. Each patient will be in the study till his/her stay in the PICU.

Study site: The study will be conducted in patients admitted to the PICU of KEM hospital, Mumbai, which is a tertiary care, 14-bedded PICU with state-of-art facilities including mechanical ventilators, non-invasive monitors and other devices for delivering critical care. It is manned by at least 4 resident medical officers round the clock. One Additional Professor looks after the day-to-day clinical and administrative matters of the PICU and is assisted by one Associate Professor and one Assistant Professor. Fellows (MUHS) and senior registrars are also posted in the PICU (when available).

Inclusion Criteria: All consecutive patients admitted to the PICU with the diagnosis of a respiratory illness from the age group of 1 month to 12 years of either gender will be enrolled in the study.

Exclusion Criteria:

The following patients will be excluded from this study-

1. Patients whose parent/ guardian refuse to give informed consent.

2. Patients admitted with non-respiratory illnesses who develop a new respiratory illness after 48 hours admission to PICU.

3. Patients admitted for non-respiratory illness/post-trauma cases/ post-operative cases developing respiratory complications during their PICU stay and patients with tachypnea due to metabolic acidosis.

**Confidentiality:**The participant’s details will not be disclosed at any point of time.

Total number of patients to be studied (sample size calculation):

It has been noticed that the average number of admissions to the Pediatric ICU is around 400 per year. Of these, about 20% patients are expected to have primary respiratory illnesses.24

So, taking e as 0.05; p = 0.2 , N = 400 & z = 1.96, the sample size is calculated to be 152.

Z = 1.96; p = Prevalence of respiratory illnesses in PICU setting = 20% = 0.2; N = Number of PICU admissions in 12 months = 400; e = Margin of error = 0.05.

Sample size calculation:

(1.96*1.96) * 0.2 (1-0.2)

---

0.05 * 0.05

————————————————-

1

• (1.96*1.96) * 0.2 (1-0.2)

---

0.05 * 0.05 * 500

= 152

Study Procedure & Data Recording:

The patient’s daily medical records will be scrutinized from admission until discharge from PICU or until death of the patient or transfer to the pediatric ward, whichever is earlier. Readmission of the same patient to PICU will be counted as a separate case enrolled. This study will not entail performing any new/ additional investigation or new/ additional treatment or any new/ additional financial burden to the hospital or financial burden to the parent/ guardian.

Following data/ information will be recorded in a pre-designed case record form- CRF (from the patient’s hospital case sheets/ indoor medical papers)-

·       Demographic details: age (in months), sex, weight, socio-economic status, duration of PICU stay (less than/ equal to 7 days & more than 7 days) and hospital stay (less than/ equal to 14 days & more than 14 days).

·       Clinical Details: Indication of PICU admission, Final complete diagnosis (with etiology of the respiratory illness), Ventilation related data with duration (invasive/ non-invasive/ both), co-morbidities (severe malnutrition, incomplete immunization for the given age, cardiac illness, respiratory malformations, gastroesophageal reflux- GER, other organ failure, etc) & complications (Recorded in Yes/ No format for the following parameters- pleural effusion, empyema, shock, sepsis, ventilator associated pneumonia- VAP, nosocomial blood stream infection, and thrombocytopenia).

·       Outcome: Final outcome of the patient (survival/ death/ discharge taken against medical advice i.e. DAMA with survival at discharge), length of PICU stay and length of hospital stay.

·       Predictors of mortality: The factors which will be analyzed for their effect on mortality will include-- age, sex, malnutrition, socio-economic status- Kuppuswanmy scale, severity of illness (PIM 2 score), etiology of respiratory illness, need for ventilation (invasive mechanical ventilation/ non-invasive mechanical ventilation/ both types), total duration of ventilation in hours, presence of co-morbidities, occurrence of complications, duration of PICU stay (less than/ equal to 7 days and more than 7 days)& duration of hospital stay (less than/ equal to 14 days & more than 14 days).

·       Predictors of Length of Stay (LOS) i.e. PICU stay (less than/ equal to 7 days and more than 7 days)& duration of hospital stay (less than/ equal to 14 days & more than 14 days): The factors which will be analyzed for their effect on LOS will include-- age, sex, malnutrition, socio-economic status- Kuppuswanmy scale, severity of illness (PIM 2 score), etiology of respiratory illness, need for ventilation (invasive mechanical ventilation/ non-invasive mechanical ventilation/ both types), total duration of ventilation in hours, presence of co-morbidities, and occurrence of complications.

Plan for Statistical Analysis:

The following statistical tests will be applied for the various variables and their analysis--

1. The etiology of the respiratory illness, indication for PICU admission, need for ventilation, type of ventilation (invasive/ non-invasive), co-mobidities, complications & final outcome will be listed as percentage of total patients enrolled.

2. Age, weight, duration of PICU stay & duration of hospital stay will be expressed as mean, standard deviation, median and mode.

3. Predictors of mortality will be analyzed by chi-square test (p<0.05 will be considered as statistically significant). Regression analysis will be done for the factors which are found to be significant by univariate analysis.

Expected Outcomes:

This study will help --

1.   To understand the etiology & different types of respiratory illnesses requiring PICU admission and their outcome.

2.   To rationalize the resources and in framing admission and discharge policy for the patients in PICU.

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