Epidemiology of Respiratory Insufficiency in Critical Care

NCT01268410 | Completed DMC

• 1 other identifier: HSL2010/51
• Study Type: observational
• Target: 773
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Failure

Keywords

Acute respiratory failure; Acute lung injury; Acute respiratory distress syndrome; Mechanical Ventilation; Non-Invasive Ventilation

Outcome Measures

Primary Outcomes (1)

• hospital mortality

  15 days

Secondary Outcomes (1)

• incidence of acute respiratory failure

  15 days

Study Arms (1)

acute respiratory failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to intensive care units in Brazil with acute respiratory failure

You may qualify if:

• 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.

You may not qualify if:

• Tracheostomized patients
• Patients admitted to ICUs for monitoring or in post-operatory of non-complicated surgeries.
• Patients with cancer on terminal stage.

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Study Sites (1)

Hospital Sirio-Libanes

São Paulo, São Paulo, 01308050, Brazil

Location

Related Publications (2)

• Serafini SC, van Meenen DMP, Pisani L, Neto AS, Ball L, de Abreu MG, Algera AG, Azevedo L, Bellani G, Dondorp AM, Fan E, Laffey JG, Pham T, Tschernko EM, Schultz MJ, van der Woude MCE; ERICC; LUNG SAFE; PRoVENT; PRoVENT-iMiC-investigators. Different ventilation intensities among various categories of patients ventilated for reasons other than ARDS--A pooled analysis of 4 observational studies. J Crit Care. 2024 Jun;81:154531. doi: 10.1016/j.jcrc.2024.154531. Epub 2024 Feb 10.

  PMID: 38341938 DERIVED

• Azevedo LC, Park M, Salluh JI, Rea-Neto A, Souza-Dantas VC, Varaschin P, Oliveira MC, Tierno PF, dal-Pizzol F, Silva UV, Knibel M, Nassar AP Jr, Alves RA, Ferreira JC, Teixeira C, Rezende V, Martinez A, Luciano PM, Schettino G, Soares M; ERICC (Epidemiology of Respiratory Insufficiency in Critical Care) investigators. Clinical outcomes of patients requiring ventilatory support in Brazilian intensive care units: a multicenter, prospective, cohort study. Crit Care. 2013 Apr 4;17(2):R63. doi: 10.1186/cc12594.

  PMID: 23557378 DERIVED

MeSH Terms

Conditions

Acute Lung Injury; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Luciano CP Azevedo, MD, PhD

  Hospital Sirio-Libanes

  STUDY CHAIR

• Marcelo Park, MD, PhD

  Hospital Sirio-Libanes

  PRINCIPAL INVESTIGATOR

• Guilherme PP Schettino, MD, PhD

  Hospital Sirio-Libanes

  PRINCIPAL INVESTIGATOR

• Marcio Soares, MD, PhD

  Instituto D'Or de Pesquisa e Ensino

  PRINCIPAL INVESTIGATOR

• Jorge IF Salluh, MD, PhD

  Instituto D'Or de Pesquisa e Ensino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physincian

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: December 30, 2010
• Study Start: June 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 20, 2012

Record last verified: 2012-09

Locations

BR (1)