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Clinical Trials/NCT01966861
NCT01966861UnknownPhase 3

Weaning From Mechanical Ventilation Guided by Lung Ultrasound (Brazilian WEANLUS)

D'Or Institute for Research and Education2 sites in 1 country300 target enrollmentStarted: March 1, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Sponsor
Enrollment
300
Locations
2
Primary Endpoint
Respiratory distress requiring re-intubation or non-invasive ventilation
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Mechanically ventilated >48h

Exclusion Criteria

  • •Moderate/Severe COPD
  • •Spinal cord lesion
  • •Neuromuscular disease (previous)
  • •Lung fibrosis
  • •Tracheostomy
  • •Heart failure (EF<50%)
  • •Lung/pleural cancer
  • •inadequate "window"for LUS

Outcomes

Primary Outcomes

Respiratory distress requiring re-intubation or non-invasive ventilation

Time Frame: 48hours

Secondary Outcomes

  • Hospital Mortality(Hospital death/discharge (up to 60 days))
  • 28-day mortality(28 days)
  • Adverse events(48h)

Investigators

Sponsor
D'Or Institute for Research and Education
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jorge Salluh

MD, PhD

D'Or Institute for Research and Education

Study Sites (2)

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