NCT05918172

Comparison of the Frequency of Ventilator-Associated Pneumonia in Intubated Patients Followed Up With Automatic Cuff Pressure Controller and Manual Cuff Pressure Controller in Pediatric Intensive Care

Comparison of the Frequency of Ventilator-Associated Pneumonia in Intubated Patients Followed Up With Automatic Cuff Pressure Controller and Manual Cuff Pressure Controller in Pediatric Intensive Care; A Randomized Controlled Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 241 (actual)
• Sponsor: Istanbul Medeniyet University · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ventilator-associated Pneumonia

Interventions

Type	Name	Description
DEVICE	endotracheal cuff pressure manual measurement	The cuff pressure of the tracheal tube will be monitored every 8 hours in the manual group using a portable manometer. The target endotracheal tube cuff pressure will be 20 cm H2O during the follow-up of patients. Before starting to work, PICU nurses will be given training in recognizing and preventing VAP and using cuff pressure measuring devices. The application period will continue from the day of intubation to extubation or a maximum of 14 days. Study data forms will be filled out by PICU nurses and monitored by physicians. The research group will periodically observe PICU personnel to verify adherence to the protocol. While patients are mechanically ventilated, VIP findings will be routinely screened at each daily visit.
DEVICE	endotracheal cuff pressure automatic measurement	The cuff pressure of the tracheal tube will be monitored continuously using a pneumatic device in the automatic group. The target endotracheal tube cuff pressure will be 20 cm H2O during the follow-up of patients. Before starting to work, PICU nurses will be given training in recognizing and preventing VAP and using cuff pressure measuring devices. The application period will continue from the day of intubation to extubation or a maximum of 14 days Study data forms will be filled out by PICU nurses and monitored by physicians. The research group will periodically observe PICU personnel to verify adherence to the protocol. While patients are mechanically ventilated, VIP findings will be routinely screened at each daily visit.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-06-01
• Completion: 2024-07-10
• First posted: 2023-06-26
• Last updated: 2026-03-17

Locations

1 site across 1 country: Turkey (Türkiye)