Effectiveness of a VAP Prevention Bundle in the PICU

Ventilator Associated Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03763695
• Other study ID #: 1855
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: December 2018
• Source: Policlinico Universitario Agostino Gemelli
• Contact: Orazio Genovese, MD
• Phone: 0630153125
• Email: orazio.genovese[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• age < 18 years

• patients receiving mechanical ventilation for more than 48 hours

Exclusion Criteria:

• no informed consent

• pregnancy

• previous endotracheal antibiotic therapy

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

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.
• 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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma	RM

Sponsors (7)

Lead Sponsor	Collaborator
Policlinico Universitario Agostino Gemelli	Antonio D Addona, Antonio Maria Dell Anna, Giorgio Conti, Giuseppe Bello, Ilaria Vitali, Leonardo Dassatti

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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