Ventilator-Associated Events: Prevalence, Outcome and Preventability

The aim of this study is to determine the prevalence of ventilator-associated events (VAE). To analyze the patients profile, morbidity and mortality compared to patients who did not develope VAE. The preventability of VAE will be assessed by comparing the percentage of adherence to the bundle of preventive measures among patients who developed and did not develope VAE.

Study Overview

• Status: Completed
• Conditions: Ventilator-Associated Lung Injury

Detailed Description

This is a retrospective analysis of prospectively collected data, approved by the Research Ethics Committee of Hospital Sao Domingos. The need for informed consent was waived.

Included were all patients admitted to a surgical (13 beds) and medical (32 beds) of a tertiary hospital over a 3-year period (February 2013 to January 2016), aged above 18 years and submitted to mechanical ventilation for at least 4 days.

At admission and daily the following data were collected: head of bed elevation, daily interruption of sedation, gastric ulcer prevention, Thromboembolism prophylaxis, aspiration of subglottic secretions, oral care with chlorhexidine gluconate and monitoring of endotracheal tube cuff pressure.

Identification of VAE, Ventilator-associated condition (VAC), Infectious condition associated to mechanical ventilation (IVAC) and ventilator-associated pneumonia possible and probable followed definition criteria of the National Healthcare Safety Network / Center for Disease Control and Prevention.

The percentage of adherence to the bundle of preventive measures of VAE prevention was registered.

• Study Type: Observational
• Enrollment (Actual): 400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to a medical and a surgical ICUs over a 3-year period aged above 18 years and submitted to mechanical ventilation for at least 4 days.

Description

Inclusion Criteria:

• Patients admitted to a medical and a surgical ICUs over a 3-year period aged above 18 years and submitted to mechanical ventilation for at least 4 days.

Exclusion Criteria:

• Patients aged bellow 18 years and those that remained under mechanical ventilation less than 4 days.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients who developed ventilator-associated events	1 year
All cause Mortality	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Duration of mechanical ventilation	1 year
Percentage of adherence to the package of VAE preventive measures	1 year

Collaborators and Investigators

• Sponsor: Hospital Sao Domingos
• Investigators: Principal Investigator: JOSE R AZEVEDO, MA, PhD, Hospital São Domingos

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: November 20, 2016
• First Submitted That Met QC Criteria: November 25, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Estimate): November 30, 2016
• Last Update Submitted That Met QC Criteria: November 25, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury
• Other Study ID Numbers: CONEP 1.449.854