Effectiveness of a VAP Prevention Bundle in the PICU

NCT ID: NCT03763695

Last Updated: 2018-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

242 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ventilator Associated Pneumonia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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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)

Evaluation of VAP incidence before the protocol introduction

Intervention Type OTHER

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)

Measures for the VAP prevention in the PICU

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* no informed consent
* pregnancy
* previous endotracheal antibiotic therapy
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ilaria Vitali

UNKNOWN

Sponsor Role collaborator

Antonio Maria Dell Anna

UNKNOWN

Sponsor Role collaborator

Leonardo Dassatti

UNKNOWN

Sponsor Role collaborator

Giuseppe Bello

UNKNOWN

Sponsor Role collaborator

Giorgio Conti

UNKNOWN

Sponsor Role collaborator

Antonio D Addona

UNKNOWN

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Orazio Genovese

Medical Doctor, pediatric intensive care unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giorgio Conti, MD

Role: STUDY_CHAIR

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

Locations

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Fondazione Policlinico Universitario Agostino Gemelli

Roma, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Orazio Genovese, MD

Role: CONTACT

0630153125

Facility Contacts

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Orazio Genovese, MD

Role: primary

Other Identifiers

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1855

Identifier Type: -

Identifier Source: org_study_id

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