Effectiveness of Continuous Automatic Endotracheal Cuff Pressure Monitoring in Preventing Ventilator-Associated Pneumonia in the Pediatric Intensive Care Unit: A Randomized Controlled Trial
Abstract
BACKGROUND
Ventilator-associated pneumonia (VAP) is a major healthcare-associated infection in critically ill children, primarily driven by microaspiration around the endotracheal tube cuff.
RESEARCH QUESTION
Does continuous automatic cuff pressure monitoring (CACPM) reduce the incidence of VAP compared to intermittent manual cuff pressure monitoring (IMCPM) in critically ill pediatric patients requiring mechanical ventilation?
STUDY DESIGN AND METHODS
In this open-label, randomized controlled superiority trial, pediatric patients requiring mechanical ventilation for ≥48 hours were randomly assigned (1:1) to either CACPM or IMCPM. The target cuff pressure was strictly maintained at 20-25 cmH2O. The primary outcome was the proportion of patients developing VAP within 28 days following intubation, evaluated in the intention to treat population. Secondary outcomes included time to VAP diagnosis and target pressure compliance. Statistical approaches included Kaplan-Meier survival analysis and multivariable Cox proportional hazard regression.
RESULTS
Among 241 randomized patients, ITT analysis showed lower VAP with CACPM than IMCPM (13.3% vs 24.0%; risk difference, -10.6 percentage points; 95% CI, -20.3 to -0.8; P=0.034), with similar PP findings (15.0% vs 26.6%; P=0.044). ITT incidence density was 15.7 vs 27.1 per 1,000 ventilator-days (IRR, 1.73; 95% CI, 0.94-3.18; P=0.080). Unadjusted time-to-VAP was nonsignificant (HR, 1.80; 95% CI, 0.976-3.321; P=0.060), whereas adjusted Cox…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 241 participants or records.
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