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Clinical Trials/NCT01966861
NCT01966861
Unknown
Phase 3

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

D'Or Institute for Research and Education1 site in 1 country300 target enrollmentMarch 2016
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ConditionsAcute Respiratory Failure

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Acute Respiratory Failure
Sponsor
D'Or Institute for Research and Education
Enrollment
300
Locations
1
Primary Endpoint
Respiratory distress requiring re-intubation or non-invasive ventilation
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
May 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Jorge Salluh

MD, PhD

D'Or Institute for Research and Education

Eligibility Criteria

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)

Study Sites (1)

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