Prevention Ventilator Associated Pneumonia (REINA)

February 9, 2014 updated by: Maria Jesus Perez

Impact of 4 Sequential Measures on the Prevention of Ventilator Associated Pneumonia in Major Heart Surgery Intensive Care Unit

The objective of the investigators work was to evaluate the impact of 4 sequentially implemented measures for preventing VAP in a major heart surgery ICU. The measures were a specific training program, aspiration of subglottic secretions (ASS), introduction of an inclinometer to improve the semirecumbent position, and reinforcement of oral care with chlorhexidine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1534

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Hopsital general Universitario Gregorio Marañón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients with heart surgery admitted in critical care unit during the study period

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: bundle implementation
The measures were a specific training program, aspiration of subglottic secretions (ASS), introduction of an inclinometer to improve the semirecumbent position, and reinforcement of oral care with chlorhexidine.
Other: Bundle implementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change (reduction) in the incidence density of Ventilator associated pneumonia (VAP)
Time Frame: Baseline and up to 35 months
Change (reduction) in the incidence density of VAP
Baseline and up to 35 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change(length) in Intensive Care Unit (ICU) stay
Time Frame: Baseline and up to 35 months
Baseline and up to 35 months
Change (number of days) in Mechanical Ventilator (MV) per ICU stay
Time Frame: Baseline and up to 35 months
Baseline and up to 35 months
Change in mortality rate
Time Frame: Baseline and up to 35 months
Baseline and up to 35 months
Change in cost of antimicrobial acquisition during ICU stay
Time Frame: Baseline and up to 35 months
Baseline and up to 35 months
Change in compliance with the measures
Time Frame: Baseline and up to 35 months
Baseline and up to 35 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Jesus Perez

Collaborators

Fondo de Investigacion Sanitaria
Ciber de Enfermedades Respiratorias
Fundación Rafael del Pino

Investigators

  • Principal Investigator: Maria Jesus Perez, RN, Hospital General Universitario Gregorio Marañon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 9, 2014

First Posted (ESTIMATE)

February 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2014

Last Update Submitted That Met QC Criteria

February 9, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REINA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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