Epidemiology of Respiratory Insufficiency in Critical Care

Acute Respiratory Failure Clinical Trial

— ERICC  

Official title:

Epidemiological Study of Patients With Acute Respiratory Failure Admitted to Brazilian Intensive Care Units

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268410
• Other study ID #: HSL2010/51
• Status: Completed
• Phase: N/A
• First received: December 29, 2010
• Last updated: September 19, 2012
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: September 2012
• Source: Hospital Sirio-Libanes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

Acute respiratory failure is a common entity in intensive care units nowadays and is associated with significant morbidity and mortality, thus representing a major health problem. Most of the published epidemiological studies on this condition were performed when modern ventilatory strategies and non-invasive ventilation were not available. Therefore, an actual evaluation on the incidence and outcomes of this syndrome is mandatory. We will perform an observational prospective study of patients admitted with acute respiratory insufficiency in several ICUs in Brazil.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 773
• Est. completion date: November 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Need for non-invasive or invasive mechanical ventilation for more than 24 hours in the first 48 hours of admission to the intensive care unit.

Exclusion Criteria:

• Tracheostomized patients

• Patients admitted to ICUs for monitoring or in post-operatory of non-complicated surgeries.

• Patients with cancer on terminal stage.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Locations

Country	Name	City	State
Brazil	Hospital Sirio-Libanes	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sirio-Libanes

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital mortality		15 days	No
Secondary	incidence of acute respiratory failure		15 days	No