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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03763695
Other study ID # 1855
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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