Prevention Ventilator Associated Pneumonia

Ventilator-associated Pneumonia Clinical Trial

— REINA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060045
• Other study ID #: REINA
• 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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-associated Pneumonia

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