TO ASSESS THE IMPACT OF ORAL DECONTAMINATION WITH CHLORHEXIDINE (0.2%) VS NORMAL SALINE ON INCIDENCE OF VENTILATOR ASSOCIATED PNEUMONIA IN MECHANICALLY VENTILATED CHILDREN: AN OPEN LABEL PARALLEL GROUP RANDOMIZED CONTROLLED TRIAL

Phase 3

Not yet recruiting

Conditions: Intraoperative and postproceduralcomplications and disorders of respiratory system, not elsewhere classified,

Brief Summary: Ventilator-associated pneumonia (VAP) is a hospital-acquired infection affecting the lower respiratory tract in individuals on mechanical ventilation, typically manifesting > 48 hours after ventilation initiation. Its correlation with prolonged ventilator requirement, extended stays in intensive care and hospitals, increased mortality rates, and substantial financial burdens are evident.

During critical illness, the stomach is often colonized by Gram-negative bacteria, Streptococcus spp. and Candida albicans, which, by gastrointestinal reflux, colonize the oral cavity. In cases of VAP, the germs isolated in oral secretion and sputum are the same. In addition, pre-existing dental disease is associated with community-acquired pneumonia and hospital-acquired pneumonia. Thus, in VAP prevention bundles, oral hygiene is an important strategy to minimize the chance of tracheobronchitis and pneumonia.

Despite meta-analyses and randomized controlled trials revealing mixed results, the effectiveness of chlorhexidine mouthwash in preventing VAP is yet to be proven.

Recruitment & Eligibility

Inclusion Criteria

Children between 1 month to 17 years receiving mechanical ventilation 2) Parents or guardians giving informed written consent for enrolment of children into study.

Exclusion Criteria

Primary Outcome Measures

Name	Time	Method
To compare the incidence of ventilator associated pneumonia in mechanically ventilated children randomly allocated to be given oral chlorhexidine (0.2%) or NS.	Incidence of Ventilator associated pneumonia to be calculated at the time of outcome of patient(Discharge/Death/LAMA).

Secondary Outcome Measures

Name	Time	Method
To compare the duration of mechanical ventilation in both groups	Until the patient is extubated;
Length of hospital stay	Until the outcome (death, discharge or LAMA)
Length of PICU stay	Until the outcome (death, discharge or LAMA)
To compare PICU mortality in each group	Until the outcome (death, discharge or LAMA)
To compare Hospital mortality in each group	Until the outcome (death, discharge or LAMA)

Locations (1): All India Institute of Medical Sciences, Jodhpur
🇮🇳
Jodhpur, RAJASTHAN, India
All India Institute of Medical Sciences, Jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
Dr Deependra Singh
Principal investigator
7895920979
iamdeependra16@gmail.com