To assess the impact of oral decontamination with chlorhexidine (0.2%) vs normal saline on the incidence of ventilator-associated pneumonia in mechanically ventilated children: an open-label parallel-group randomized controlled trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 186
- Locations
- 1
- Primary Endpoint
- To compare the incidence of ventilator associated pneumonia in mechanically ventilated children randomly allocated to be given oral chlorhexidine (0.2%) or NS.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, variable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 1.00 Month(s) to 17.00 Year(s) (—)
- Sex
- All
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
- •Children who are transferred to our hospital already intubated.
- •Children with primary or acquired immunodeficiencies.
Outcomes
Primary Outcomes
To compare the incidence of ventilator associated pneumonia in mechanically ventilated children randomly allocated to be given oral chlorhexidine (0.2%) or NS.
Time Frame: Incidence of Ventilator associated pneumonia to be calculated at the time of outcome of patient(Discharge/Death/LAMA).
Secondary Outcomes
- To compare PICU mortality in each group(Until the outcome (death, discharge or LAMA))
- 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))
- To compare Hospital mortality in each group(Until the outcome (death, discharge or LAMA))
- Length of PICU stay(Until the outcome (death, discharge or LAMA))