NCT03763695

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
242

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 4, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

December 4, 2018

Status Verified

December 1, 2018

Enrollment Period

2 years

First QC Date

September 18, 2018

Last Update Submit

December 1, 2018

Conditions

Ventilator Associated Pneumonia

Keywords

Pediatric intensive care unitOral Hygiene CareChlorhexidineBroncho-alveolar lavagePharyngeal swab

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Prevalence of orotracheal bacterial colonization in ventilated patients

    From 48 hours after intubation to 48 hours after extubation

Study Arms (2)

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

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

Interventions

Measures for the VAP prevention in the PICUOTHER

Oral hygiene care (i.e chlorhexidine swab); clean and dry ventilator circuits; head positioning at 45 degrees.

Prospective group
Evaluation of VAP incidence before the protocol introductionOTHER

evaluation of VAP incidence in our pediatric population of intensive care patients before the implementation of the protocol for VAP prevention

Retrospective control group

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • no informed consent
  • pregnancy
  • previous endotracheal antibiotic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Giorgio Conti, MD

    Università Cattolica del Sacro Cuore; Fondazione Policlinico Universitario Agostino Gemelli; IRCCS

    STUDY CHAIR

Central Study Contacts

Orazio Genovese, MD

CONTACT

0630153125orazio.genovese@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, pediatric intensive care unit

Study Record Dates

First Submitted

September 18, 2018

First Posted

December 4, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

June 30, 2020

Last Updated

December 4, 2018

Record last verified: 2018-12

Locations

IT(1)