Prospective Study of Frequency, Risk Factors and Outcome of Ventilator-associated Pneumonia in a Tertiary Care Pediatric Intensive Care Unit.

Aims & Objectives:

For the patients admitted to a tertiary care Pediatric Intensive Care Unit (PICU) and on mechanical ventilation for  >48 hours --

•  To study the frequency of patients with VAP.

•  To evaluate the risk factors for patients with VAP.

•  To study the outcome (survival/ death) of patients with VAP.

•  To study the length of PICU stay and length of hospital stay in patients with VAP.

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 enrolment 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 their clinical condition stabilizes and when they are in a position to give the assent.

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

Study duration: The study will be conducted over a total period of 18 months (prospectively) after approval from the IEC. Enrolment will be done for 12 months or till the expected sample size is reached. 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 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 children aged >28 days to <12 years of either gender on mechanical ventilation for more than 48 hours (intubated either in ward, EPR or PICU) will be included.

Exclusion Criteria: Patients whose parent/ guardian refuse to give informed consent will be excluded from this study. Also patients who die within 48 hours of initiating mechanical ventilation will be excluded.

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

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

• Convenience sampling: All consecutive patients admitted to PICU over a period of 1 year with mechanical ventilation for >48 hours will be enrolled. It has been noticed that the average number of admissions to the Pediatric ICU is around 400 per year. Of these about 340 are ventilated. Of the ventilated patients about 40 die within 48 hours of admission. Hence expected sample size is 300.

• Each patient will be in the study throughout his/ her PICU stay (till transferred out of PICU/ till death).

• Of the patients enrolled, those who develop VAP will be labelled as the “VAP Group” and those who do not develop VAP will be “No VAP Group”.

The patient’s daily medical records will be scrutinized from admission until discharge from PICU or until death of the patient. 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.

Plan for Statistical Analysis:

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

• Age, weight, duration of PICU stay and duration of hospital stay will be expressed as mean, median, mode & SD.

•  Frequency of VAP and Risk factors of VAP will be listed as percentage of total patients enrolled. Frequency of VAP will also be expressed as per 1000 ventilator days (invasive only )

•  Predictors of mortality & LOS will be analyzed by Chi-square test and a p-value less than 0.05 will be considered to be significant.

Expected Outcomes:

This study will help to

• Determine the current frequency of VAP & its risk factors.

• Understand the mortality and morbidity associated with VAP.

This data will help in planning preventive strategies as well as better treatment strategies for patients developing VAP or patients who are at risk for VAP in the PICU.