NCT02977676

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

November 20, 2016

Last Update Submit

November 25, 2016

Conditions

Ventilator-Associated Lung Injury

Outcome Measures

Primary Outcomes (2)

  • Number of patients who developed ventilator-associated events

    1 year

  • All cause Mortality

    1 year

Secondary Outcomes (2)

  • Duration of mechanical ventilation

    1 year

  • Percentage of adherence to the package of VAE preventive measures

    1 year

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • JOSE R AZEVEDO, MA, PhD

    Hospital Sao Domingos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinator of ICU

Study Record Dates

First Submitted

November 20, 2016

First Posted

November 30, 2016

Study Start

February 1, 2013

Primary Completion

January 1, 2016

Last Updated

November 30, 2016

Record last verified: 2016-11