NCT02060045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,534

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

2.6 years

First QC Date

February 4, 2014

Last Update Submit

February 9, 2014

Conditions

Keywords

bundlepreventionDisturbance; Heart, Functional, Postoperative, Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Change(length) in Intensive Care Unit (ICU) stay

    Baseline and up to 35 months

  • Change (number of days) in Mechanical Ventilator (MV) per ICU stay

    Baseline and up to 35 months

  • Change in mortality rate

    Baseline and up to 35 months

  • Change in cost of antimicrobial acquisition during ICU stay

    Baseline and up to 35 months

  • Change in compliance with the measures

    Baseline and up to 35 months

Study Arms (1)

bundle implementation

EXPERIMENTAL

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

Interventions

bundle implementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopsital General Universitario Gregorio Marañon

Madrid, Madrid, 28007, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Jesus Perez, RN

    Hospital General Universitario Gregorio Marañón

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
RN

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 11, 2014

Study Start

November 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations