Effectiveness of a VAP Prevention Bundle in the PICU

• Conditions: Ventilator Associated Pneumonia
• Interventions: Other: Evaluation of VAP incidence before the protocol introduction; Other: Measures for the VAP prevention in the PICU

• Registration Number: NCT03763695
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

This observational monocentric prospective study aims to evaluate the efficacy of new measures for ventilator associated pneumonia (VAP) management in the pediatric population in the pediatric intensive care unit (PICU) of Fondazione Policlinico Agostino Gemelli of 8 beds. The investigators will compare the incidence of VAP in the group of patients in which this protocol has been implemented to a retrospective control group of patients before the new protocol implementation. VAP bundle includes oral care hygiene measures (i.e chlorhexidine swab), to keep clean and dry ventilator circuits and head positioning at 45 degrees.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-09-18
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-01
• Last Update Submitted: 2018-12-01
• Study First Posted: 2018-12-04
• Last Update Posted: 2018-12-04
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

• age < 18 years
• patients receiving mechanical ventilation for more than 48 hours

Exclusion Criteria

• no informed consent
• pregnancy
• previous endotracheal antibiotic therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective control group	Evaluation of VAP incidence before the protocol introduction	Patients admitted in our PICU before the implementation of the protocol for VAP prevention (from 01/01/2016 to 12/31/2017)
Prospective group	Measures for the VAP prevention in the PICU	Patients admitted to our PICU since the VAP bundle has been introduced in the clinical practice (from 01/01/2018)

Primary Outcome Measures

Name	Time	Method
VAP incidence	From 48 hours after intubation to 48 hours after extubation	Incidence of VAP in pediatric patients intubated for more than 48 hours

Secondary Outcome Measures

Name	Time	Method
Prevalence of orotracheal bacterial colonization in ventilated patients	From 48 hours after intubation to 48 hours after extubation	Evaluation of orotracheal bacterial colonization in pediatric patients undergoing mechanical ventilation twice a week

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli; 🇮🇹 Roma, RM, Italy