Acute Respiratory FailureERICCNCT01268410
Epidemiology of Respiratory Insufficiency in Critical Care
An observational study of Acute Respiratory Failure, run by Hospital Sirio-Libanes at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- How many people
- 773 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2011to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to intensive care units in Brazil with acute respiratory failure
Who may be able to join
- 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.
Who cannot join
- Tracheostomized patients
- Patients admitted to ICUs for monitoring or in post-operatory of non-complicated surgeries.
- Patients with cancer on terminal stage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiological Study of Patients With Acute Respiratory Failure Admitted to Brazilian Intensive Care Units
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
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acute respiratory failure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital mortality
Measured: 15 days
Secondary outcomes (1)
incidence of acute respiratory failure
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2010 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederico Perego Costa, Hospital Sirio-Libanes
- Investigators
- Luciano CP Azevedo, MD, PhD, Study chair, Hospital Sirio-LibanesMarcelo Park, MD, PhD, Principal investigator, Hospital Sirio-LibanesGuilherme PP Schettino, MD, PhD, Principal investigator, Hospital Sirio-LibanesMarcio Soares, MD, PhD, Principal investigator, Instituto D'Or de Pesquisa e EnsinoJorge IF Salluh, MD, PhD, Principal investigator, Instituto D'Or de Pesquisa e Ensino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268410
- Sponsor's protocol ID
- HSL2010/51
- Acronym
- ERICC
- Status last verified
- Sep 2012
- First submitted
- 29 Dec 2010
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38341938Azevedo 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.
PubMed 23557378
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Patients With Acute Respiratory Failure Admitted to Brazilian Intensive Care Units
- ClinicalTrials.gov ID
- NCT01268410
- Acronym / sponsor ID
- ERICC / HSL2010/51
- Conditions
- Acute Respiratory Failure
- Keywords
- Acute respiratory failure, Acute lung injury, Acute respiratory distress syndrome, Mechanical Ventilation, Non-Invasive Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 773 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 30 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute respiratory failure | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to intensive care units in Brazil with acute respiratory failure
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Tracheostomized patients
- Patients admitted to ICUs for monitoring or in post-operatory of non-complicated surgeries.
- Patients with cancer on terminal stage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hospital mortality
Time frame: 15 days
1 secondary outcome
incidence of acute respiratory failure
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
- Derived from this study: PubMed 38341938Serafini 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.
- Derived from this study: PubMed 23557378Azevedo 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.
Related trials for Acute Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciano CP Azevedo, MD, PhD study chair
Hospital Sirio-Libanes
Marcelo Park, MD, PhD principal investigator
Hospital Sirio-Libanes
Guilherme PP Schettino, MD, PhD principal investigator
Hospital Sirio-Libanes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure, run by Hospital Sirio-Libanes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital mortality (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01268410, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2012.