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Prevention Ventilator Associated Pneumonia (REINA)

Primary Purpose

Ventilator-associated Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Bundle implementation
Sponsored by
Maria Jesus Perez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator-associated Pneumonia focused on measuring bundle, prevention, Disturbance; Heart, Functional, Postoperative, Cardiac Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Sites / Locations

  • Hopsital General Universitario Gregorio Marañon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bundle implementation

Arm Description

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.

Outcomes

Primary Outcome Measures

Change (reduction) in the incidence density of Ventilator associated pneumonia (VAP)
Change (reduction) in the incidence density of VAP

Secondary Outcome Measures

Change(length) in Intensive Care Unit (ICU) stay
Change (number of days) in Mechanical Ventilator (MV) per ICU stay
Change in mortality rate
Change in cost of antimicrobial acquisition during ICU stay
Change in compliance with the measures

Full Information

First Posted
February 4, 2014
Last Updated
February 9, 2014
Sponsor
Maria Jesus Perez
Collaborators
Ciber de Enfermedades Respiratorias, Fundación Rafael del Pino, Fondo de Investigacion Sanitaria
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1. Study Identification

Unique Protocol Identification Number
NCT02060045
Brief Title
Prevention Ventilator Associated Pneumonia
Acronym
REINA
Official Title
Impact of 4 Sequential Measures on the Prevention of Ventilator Associated Pneumonia in Major Heart Surgery Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maria Jesus Perez
Collaborators
Ciber de Enfermedades Respiratorias, Fundación Rafael del Pino, Fondo de Investigacion Sanitaria

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator-associated Pneumonia
Keywords
bundle, prevention, Disturbance; Heart, Functional, Postoperative, Cardiac Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1534 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bundle implementation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Bundle implementation
Primary Outcome Measure Information:
Title
Change (reduction) in the incidence density of Ventilator associated pneumonia (VAP)
Description
Change (reduction) in the incidence density of VAP
Time Frame
Baseline and up to 35 months
Secondary Outcome Measure Information:
Title
Change(length) in Intensive Care Unit (ICU) stay
Time Frame
Baseline and up to 35 months
Title
Change (number of days) in Mechanical Ventilator (MV) per ICU stay
Time Frame
Baseline and up to 35 months
Title
Change in mortality rate
Time Frame
Baseline and up to 35 months
Title
Change in cost of antimicrobial acquisition during ICU stay
Time Frame
Baseline and up to 35 months
Title
Change in compliance with the measures
Time Frame
Baseline and up to 35 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients with heart surgery admitted in critical care unit during the study period Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Jesus Perez, RN
Organizational Affiliation
Hospital General Universitario Gregorio Marañón
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopsital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24667011
Citation
Perez-Granda MJ, Barrio JM, Munoz P, Hortal J, Rincon C, Bouza E. Impact of four sequential measures on the prevention of ventilator-associated pneumonia in cardiac surgery patients. Crit Care. 2014 Mar 26;18(2):R53. doi: 10.1186/cc13799.
Results Reference
derived

Learn more about this trial

Prevention Ventilator Associated Pneumonia

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