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
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione Policlinico Universitario Agostino Gemelli | Roma | RM |
Lead Sponsor | Collaborator |
---|---|
Policlinico Universitario Agostino Gemelli | Antonio D Addona, Antonio Maria Dell Anna, Giorgio Conti, Giuseppe Bello, Ilaria Vitali, Leonardo Dassatti |
Italy,
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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