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Prevention Ventilator Associated Pneumonia (REINA)

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ClinicalTrials.gov Identifier: NCT02060045
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : February 11, 2014
Sponsor:
Collaborators:
Ciber de Enfermedades Respiratorias
Fundación Rafael del Pino
Fondo de Investigacion Sanitaria
Information provided by (Responsible Party):
Maria Jesus Perez, Hospital General Universitario Gregorio Marañon

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.

Condition or disease Intervention/treatment Phase
Ventilator-associated Pneumonia Other: Bundle implementation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1534 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of 4 Sequential Measures on the Prevention of Ventilator Associated Pneumonia in Major Heart Surgery Intensive Care Unit
Study Start Date : November 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change(length) in Intensive Care Unit (ICU) stay [ Time Frame: Baseline and up to 35 months ]
  2. Change (number of days) in Mechanical Ventilator (MV) per ICU stay [ Time Frame: Baseline and up to 35 months ]
  3. Change in mortality rate [ Time Frame: Baseline and up to 35 months ]
  4. Change in cost of antimicrobial acquisition during ICU stay [ Time Frame: Baseline and up to 35 months ]
  5. Change in compliance with the measures [ Time Frame: Baseline and up to 35 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060045


Locations
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Spain
Hopsital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Sponsors and Collaborators
Maria Jesus Perez
Ciber de Enfermedades Respiratorias
Fundación Rafael del Pino
Fondo de Investigacion Sanitaria
Investigators
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Principal Investigator: Maria Jesus Perez, RN Hospital General Universitario Gregorio Marañón

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Jesus Perez, RN, Hospital General Universitario Gregorio Marañon
ClinicalTrials.gov Identifier: NCT02060045     History of Changes
Other Study ID Numbers: REINA
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by Maria Jesus Perez, Hospital General Universitario Gregorio Marañon:
bundle
prevention
Disturbance; Heart, Functional, Postoperative, Cardiac Surgery

Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection