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

Phase 3

• Conditions: Acute Respiratory Failure

• Registration Number: NCT01966861
• Lead Sponsor: D'Or Institute for Research and Education

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-15
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-22
• Study Start: 2016-03
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02
• Primary Completion: 2018-12
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Respiratory distress requiring re-intubation or non-invasive ventilation	48hours

Secondary Outcome Measures

Name	Time	Method
28-day mortality	28 days
Hospital Mortality	Hospital death/discharge (up to 60 days)
Adverse events	48h	Renal dysfunction, complications of thoracocentesis, hydro-electrolite changes, hypotension

Trial Locations

Locations (1)

D'OR Institute for Research and Education; 🇧🇷 Rio de Janeiro, Brazil