Ventilator-Associated Events: Prevalence, Outcome and Preventability

Completed

• Conditions: Ventilator-Associated Lung Injury

• Registration Number: NCT02977676
• Lead Sponsor: Hospital Sao Domingos

Brief Summary

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.

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 Timeline

• Study Start: 2013-02
• Primary Completion: 2016-01
• Status Verified: 2016-11
• Study First Submitted: 2016-11-20
• Study First Submitted QC: 2016-11-25
• Last Update Submitted: 2016-11-25
• Study First Posted: 2016-11-30
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause Mortality	1 year
Number of patients who developed ventilator-associated events	1 year

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	1 year
Percentage of adherence to the package of VAE preventive measures	1 year