Effectiveness of a VAP Prevention Bundle in the PICU

Effectiveness of a Bundle of Ventilator Associated Pneumonia (VAP) Prevention in the Pediatric Intensive Care Unit (PICU): an Observational Study

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.

Study Overview

• Status: Unknown
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Other: Evaluation of VAP incidence before the protocol introduction; Other: Measures for the VAP prevention in the PICU

• Study Type: Observational
• Enrollment (Anticipated): 242

Contacts and Locations

• Study Contact: Name: Orazio Genovese, MD; Phone Number: 0630153125; Email: orazio.genovese@policlinicogemelli.it

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli
      • Contact: Orazio Genovese, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric patients admitted to our ICU requiring mechanical ventilation for more than 48 hours

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective control group; Patients admitted in our PICU before the implementation of the protocol for VAP prevention (from 01/01/2016 to 12/31/2017)	Other: Evaluation of VAP incidence before the protocol introduction; evaluation of VAP incidence in our pediatric population of intensive care patients before the implementation of the protocol for VAP prevention
Prospective group; Patients admitted to our PICU since the VAP bundle has been introduced in the clinical practice (from 01/01/2018)	Other: Measures for the VAP prevention in the PICU; Oral hygiene care (i.e chlorhexidine swab); clean and dry ventilator circuits; head positioning at 45 degrees.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAP incidence	Incidence of VAP in pediatric patients intubated for more than 48 hours	From 48 hours after intubation to 48 hours after extubation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Collaborators: Antonio Maria Dell Anna; Ilaria Vitali; Leonardo Dassatti; Giuseppe Bello; Giorgio Conti; Antonio D Addona
• Investigators: Study Chair: Giorgio Conti, MD, Università Cattolica del Sacro Cuore; Fondazione Policlinico Universitario Agostino Gemelli; IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: December 1, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 1, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Chlorhexidine; Broncho-alveolar lavage; Pediatric intensive care unit; Oral Hygiene Care; Pharyngeal swab
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 1855

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No