Acute Respiratory FailurePhase 3WEANLUS-BRNCT01966861
Weaning From Mechanical Ventilation Guided by Lung Ultrasound (Brazilian WEANLUS)
A Phase 3 study testing weaning guided by LUS (lung ultrasound) in people with Acute Respiratory Failure, run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial summary
The present study aims to evaluate the impact of a weaning strategy based on identification of early signs of respiratory distress by lung ultrasound and the consequent implementation of a "clinical optimization" protocol as compared to usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- weaning guided by LUS (lung ultrasound)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to May 2019
- Phase
- Phase 3
- 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
Who may be able to join
- Mechanically ventilated >48h
Who cannot join
- Moderate/Severe COPD
- Spinal cord lesion
- Neuromuscular disease (previous)
- Lung fibrosis
- Tracheostomy
- Heart failure (EF<50%)
- Lung/pleural cancer
- inadequate "window"for LUS
Trial locations and contacts
1 site in 1 country.
Brazil1 site
D'OR Institute for Research and Education
Rio de Janeiro, 20230-130
About this study
The present study aims to evaluate the impact of a weaning strategy based on identification of early signs of respiratory distress by lung ultrasound and the consequent implementation of a "clinical optimization" protocol as compared to usual care.
- Conditions
- Acute Respiratory Failure
- Being tested
- weaning guided by LUS (lung ultrasound)
- Keywords
- mechanical ventilation, weaning, acute respiratory failure, weaning failure, lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weaning guided by LUS (lung ultrasound)Other
Predictive early signs of respiratory distress are assessed by lung ultrasound (LUS score >14) and if present will trigger protocolised intervention (eg- fluid balance,diuretics, thoracocentesis, antibiotics when required [CPIS>6], hemglobin>8g/dl triggers transfusion)
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | Weaning as protcolised by the units' daily practice (SBT) |
| Weaning guided by lung ultrasound | Experimental | Predictive early signs of respiratory distress are assessed by lung ultrasound and if found will trigger protocolised intervention (eg- fluid balance,diuretics, thoracocentesis) Receives: Other: weaning guided by LUS (lung ultrasound) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory distress requiring re-intubation or non-invasive ventilation
Measured: 48hours
Secondary outcomes (3)
28-day mortality
Measured: 28 days
Hospital Mortality
Measured: Hospital death/discharge (up to 60 days)
Adverse events
Renal dysfunction, complications of thoracocentesis, hydro-electrolite changes, hypotension
Measured: 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startMar 2016
- Primary completionDec 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Sirio-Libanes, University of Sao Paulo, Hospital Israelita Albert Einstein
- Responsible party
- Principal investigator, Jorge Salluh, D'Or Institute for Research and Education
- Investigators
- Jorge IF Salluh, MD, PhD, Principal investigator, D'Or Institute for Research and EducationLuiz M Malbouisson, MD, PhD, Principal investigator, University of Sao PauloFabiola Prior, MD, Principal investigator, University of Sao PauloJulio Neves, MD, Principal investigator, Hospital da BahiaJean-Jacques Rouby, MD, Study chair, Paris University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966861
- Sponsor's protocol ID
- IDOR-03-2013
- Acronym
- WEANLUS-BR
- Status last verified
- Mar 2018
- First submitted
- 15 Oct 2013
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning From Mechanical Ventilation Guided by Lung Ultrasound (Brazilian WEANLUS)
- ClinicalTrials.gov ID
- NCT01966861
- Acronym / sponsor ID
- WEANLUS-BR / IDOR-03-2013
- Conditions
- Acute Respiratory Failure
- Keywords
- mechanical ventilation, weaning, acute respiratory failure, weaning failure, lung ultrasound
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Hospital Sirio-Libanes, University of Sao Paulo, Hospital Israelita Albert Einstein
- Study start
- Mar 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 22 Oct 2013 (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.
The present study aims to evaluate the impact of a weaning strategy based on identification of early signs of respiratory distress by lung ultrasound and the consequent implementation of a "clinical optimization" protocol as compared to usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –Weaning as protcolised by the units' daily practice (SBT) |
| Weaning guided by lung ultrasound | Experimental | Other: weaning guided by LUS (lung ultrasound)Predictive early signs of respiratory distress are assessed by lung ultrasound and if found will trigger protocolised intervention (eg- fluid balance,diuretics, thoracocentesis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mechanically ventilated >48h
Key exclusion criteria (8 listed)
- Moderate/Severe COPD
- Spinal cord lesion
- Neuromuscular disease (previous)
- Lung fibrosis
- Tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| weaning guided by LUS (lung ultrasound)Predictive early signs of respiratory distress are assessed by lung ultrasound (LUS score >14) and if present will trigger protocolised intervention (eg- fluid balance,diuretics, thoracocentesis, antibiotics when required [CPIS>6], hemglobin>8g/dl triggers transfusion) | Other | Weaning guided by lung ultrasound |
Primary outcome
Respiratory distress requiring re-intubation or non-invasive ventilation
Time frame: 48hours
3 secondary outcomes
28-day mortality
Time frame: 28 days
Hospital Mortality
Time frame: Hospital death/discharge (up to 60 days)
Adverse events
Time frame: 48h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
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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.
Jorge IF Salluh, MD, PhD principal investigator
D'Or Institute for Research and Education
Luiz M Malbouisson, MD, PhD principal investigator
University of Sao Paulo
Fabiola Prior, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing weaning guided by LUS (lung ultrasound) in people with Acute Respiratory Failure, run by D'Or Institute for Research and Education 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 8 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: status not confirmed, as of the sponsor's last update on 2 Mar 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Respiratory distress requiring re-intubation or non-invasive ventilation (time frame: 48hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2018.