Ventilator-Associated Events: Prevalence, Outcome and Preventability

Ventilator-Associated Lung Injury Clinical Trial

Official title:

Ventilator-Associated Events: Prevalence, Outcome and Preventability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977676
• Other study ID #: CONEP 1.449.854
• Status: Completed
• Phase: N/A
• First received: November 20, 2016
• Last updated: November 25, 2016
• Start date: February 2013

Study information

• Verified date: November 2016
• Source: Hospital Sao Domingos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Commision of Ethics in Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lung Injury
• Ventilator-Associated Lung Injury

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Domingos

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who developed ventilator-associated events		1 year	Yes
Primary	All cause Mortality		1 year	No
Secondary	Duration of mechanical ventilation		1 year	No
Secondary	Percentage of adherence to the package of VAE preventive measures		1 year	No