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

March 1, 2018 updated by: Jorge Salluh, D'Or Institute for Research and Education
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • D'OR Institute for Research and Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: usual care
Weaning as protcolised by the units' daily practice (SBT)
Experimental: Weaning guided by 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)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Respiratory distress requiring re-intubation or non-invasive ventilation
Time Frame: 48hours
48hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

D'Or Institute for Research and Education

Collaborators

University of Sao Paulo
Hospital Israelita Albert Einstein
Hospital Sirio-Libanes

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

October 15, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 22, 2013

Study Record Updates

Last Update Posted (Actual)

March 2, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDOR-03-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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