Ventilator-associated Pneumonia
Conditions
Brief 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.
Interventions
DEVICEendotracheal 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.
DEVICEendotracheal 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.
Sponsors
Istanbul Medeniyet University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of VIP incidences | january 2022 - january 2024 | The comparison of the VIP incidence in the patients followed in the manual and automatic cuff pressure measurement groups was determined as the primary outcome. |
Countries
Turkey (Türkiye)
Outcome results
None listed