Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia

All India Institute Of Medical Science (AIIMS)

Status and phase: Completed; Phase 3

Conditions: Ventilator Associated Pneumonia

Treatments: Drug: Chlorhexidine gel; Drug: Placebo gel

Study type: Interventional

Funder types: Other

Identifiers

NCT00597688

Meghna

Details and patient eligibility

About

The purpose of this study is to determine if oral mucosal application of chlorhexidine gel will prevent the development of ventilator associated pneumonia in children.

Full description

Ventilator associated pneumonia as the name suggests refers to pneumonia occurring in the setting of mechanical ventilation. It accounts of 86% of nosocomial pneumonia and in contrast to other more common nosocomial infections is accompanied by a mortality rate of upto 76% in certain settings. A number of preventive methods have been studied to reduce the rate of VAP but a consensus is lacking with regards to appropriate preventive strategies. Studies in adults have shown a beneficial effect of oral mucosal application of chlorhexidine but similar studies in pediatric population are not available. This research project aims at addressing the gap.

Enrollment: 86 patients

Sex: All

Ages: 3 months to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients in PICU requiring mechanical ventilation
2. Above the age of 3 months
3. Oro or nasotracheal intubation

Exclusion criteria

1. Known hypersensitivity to chlorhexidine
2. Inability to access the oral cavity for any reason
3. Patients with tracheostomy
4. Mechanical ventilation for more than 24 hours prior to PICU admission.
5. Death or extubation within 24 hours of ICU admission.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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86 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Chlorhexidine gel

Treatment:

Drug: Chlorhexidine gel

2

Placebo Comparator group

Description:

Placebo gel

Treatment:

Drug: Placebo gel