This study was designed to compare manual (intermittent) versus automatic (continuous) endotracheal cuff pressure monitoring for the prevention of ventilator-associated pneumonia (VAP) in mechanically ventilated pediatric intensive care patients. The study was based on the hypothesis that maintaining endotracheal cuff pressure within the optimal range may reduce the incidence of VAP.

Ventilator-associated pneumonia (VAP) is a major cause of morbidity and mortality in critically ill patients receiving mechanical ventilation. Microaspiration of bacteria-contaminated oropharyngeal and gastric secretions is considered one of the key mechanisms contributing to the development of VAP. Inadequate regulation of endotracheal tube cuff pressure, including both underinflation and overinflation, may increase the risk of microaspiration, VAP, and tracheal injury.

Intermittent manual monitoring and continuous automatic regulation of endotracheal tube cuff pressure have been used as preventive strategies against VAP. However, evidence regarding the comparative effectiveness of these two methods remains limited, particularly in the pediatric intensive care setting. This study was designed to evaluate the effectiveness of manual versus automatic cuff pressure monitoring in preventing VAP in mechanically ventilated pediatric intensive care patients.

This study was designed as a prospective, randomized, controlled, single-blind clinical trial. Eligible participants were pediatric patients aged 1 month to 18 years who required at least 48 hours of mechanical ventilation and were enrolled within 24 hours after intubation and initiation of mechanical ventilation. Participants were assigned in a 1:1 ratio to either the manual cuff pressure monitoring group or the automatic cuff pressure monitoring group according to a randomization table.

In the automatic monitoring group, endotracheal tube cuff pressure was continuously monitored and maintained at a target pressure of 20 cmH2O. In the manual monitoring group, cuff pressure was measured at 8-hour intervals, and any deviation from the target pressure was corrected at the time of assessment.

The primary objective was to compare the incidence of ventilator-associated pneumonia between the two study groups. VAP was diagnosed according to Centers for Disease Control and Prevention (CDC) criteria. Participants were also monitored for endotracheal tube-related complications, including airway injury and post-extubation upper airway findings such as stridor and suspected stenosis.

Inclusion Criteria:

• Children aged 1 month to 18 years
• Intubated and mechanically ventilated patients expected to require at least 48 hours of mechanical ventilation
• Eligibility assessed and enrollment completed within 24 hours of intubation and initiation of mechanical ventilation

Exclusion Criteria:

• Previous intubation within 14 days before enrollment
• Already receiving mechanical ventilation for more than 24 hours at the time of PICU admission or screening
• Expected duration of mechanical ventilation less than 48 hours
• Presence of tracheostomy
• Trauma-related tracheomalacia
• Stridor
• Suspected or confirmed tracheal stenosis
• Suspected or confirmed immunodeficiency
• Current or previous malignancy
• Chronic pulmonary, cardiac, or other systemic disease
• Current use of immunosuppressive medications, including corticosteroids
• Declined consent / refusal to participate

1 month to 18 years who required at least 48 hours of mechanical ventilation in picu