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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02060045
Other study ID # REINA
Secondary ID
Status Completed
Phase N/A
First received February 4, 2014
Last updated February 9, 2014
Start date November 2009
Est. completion date June 2012

Study information

Verified date February 2014
Source Hospital General Universitario Gregorio Marañon
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1534
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Other:
Bundle implementation


Locations

Country Name City State
Spain Hopsital General Universitario Gregorio Marañon Madrid

Sponsors (4)

Lead Sponsor Collaborator
Maria Jesus Perez Ciber de Enfermedades Respiratorias, Fondo de Investigacion Sanitaria, Fundación Rafael del Pino

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change (reduction) in the incidence density of Ventilator associated pneumonia (VAP) Change (reduction) in the incidence density of VAP Baseline and up to 35 months No
Secondary Change(length) in Intensive Care Unit (ICU) stay Baseline and up to 35 months No
Secondary Change (number of days) in Mechanical Ventilator (MV) per ICU stay Baseline and up to 35 months No
Secondary Change in mortality rate Baseline and up to 35 months No
Secondary Change in cost of antimicrobial acquisition during ICU stay Baseline and up to 35 months No
Secondary Change in compliance with the measures Baseline and up to 35 months No
See also
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Not yet recruiting NCT03018431 - CT Scan and Lung Ultrasonography to Improve Diagnostic of Ventilation Acquired Pneumonia in ICU N/A
Completed NCT02515617 - Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (DEMETER) N/A
Completed NCT02585180 - Subglottic Secretions Surveillance to Predict Bacterial Pathogens Involved in Ventilator-associated Pneumonia N/A
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