Weaning From Mechanical Ventilation Guided by Lung Ultrasound (Brazilian WEANLUS)
WEANLUS-BR
1 other identifier
interventional
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2016
Typical duration for phase_3
1 active site
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
First Submitted
Initial submission to the registry
October 15, 2013
CompletedFirst Posted
Study publicly available on registry
October 22, 2013
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMarch 2, 2018
March 1, 2018
2.8 years
October 15, 2013
March 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Respiratory distress requiring re-intubation or non-invasive ventilation
48hours
Secondary Outcomes (3)
28-day mortality
28 days
Hospital Mortality
Hospital death/discharge (up to 60 days)
Adverse events
48h
Study Arms (2)
usual care
NO INTERVENTIONWeaning as protcolised by the units' daily practice (SBT)
Weaning guided by lung ultrasound
EXPERIMENTALPredictive early signs of respiratory distress are assessed by lung ultrasound and if found will trigger protocolised intervention (eg- fluid balance,diuretics, thoracocentesis)
Interventions
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)
Eligibility Criteria
You may qualify if:
- Mechanically ventilated \>48h
You may not qualify if:
- Moderate/Severe COPD
- Spinal cord lesion
- Neuromuscular disease (previous)
- Lung fibrosis
- Tracheostomy
- Heart failure (EF\<50%)
- Lung/pleural cancer
- inadequate "window"for LUS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- D'Or Institute for Research and Educationlead
- Hospital Sirio-Libanescollaborator
- University of Sao Paulocollaborator
- Hospital Israelita Albert Einsteincollaborator
Study Sites (1)
D'OR Institute for Research and Education
Rio de Janeiro, 20230-130, Brazil
Study Officials
- PRINCIPAL INVESTIGATOR
Jorge IF Salluh, MD, PhD
D'Or Institute for Research and Education
- PRINCIPAL INVESTIGATOR
Luiz M Malbouisson, MD, PhD
University of Sao Paulo
- PRINCIPAL INVESTIGATOR
Fabiola Prior, MD
University of Sao Paulo
- PRINCIPAL INVESTIGATOR
Julio Neves, MD
Hospital da Bahia
- STUDY CHAIR
Jean-Jacques Rouby, MD
Paris University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 15, 2013
First Posted
October 22, 2013
Study Start
March 1, 2016
Primary Completion
December 1, 2018
Study Completion
May 1, 2019
Last Updated
March 2, 2018
Record last verified: 2018-03