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

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ClinicalTrials.gov Identifier: NCT01966861
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2013
Last Update Posted : March 2, 2018
Sponsor:
Collaborators:
Hospital Sirio-Libanes
University of Sao Paulo
Hospital Israelita Albert Einstein
Information provided by (Responsible Party):
Jorge Salluh, 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.

Condition or disease Intervention/treatment Phase
Acute Respiratory Failure Other: weaning guided by LUS (lung ultrasound) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Weaning From Mechanical Ventilation Guided by Lung Ultrasound (Brazilian WEANLUS)
Study Start Date : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019


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)




Primary Outcome Measures :
  1. Respiratory distress requiring re-intubation or non-invasive ventilation [ Time Frame: 48hours ]

Secondary Outcome Measures :
  1. 28-day mortality [ Time Frame: 28 days ]
  2. Hospital Mortality [ Time Frame: Hospital death/discharge (up to 60 days) ]
  3. Adverse events [ Time Frame: 48h ]
    Renal dysfunction, complications of thoracocentesis, hydro-electrolite changes, hypotension



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966861


Locations
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Brazil
D'OR Institute for Research and Education
Rio de Janeiro, Brazil, 20230-130
Sponsors and Collaborators
D'Or Institute for Research and Education
Hospital Sirio-Libanes
University of Sao Paulo
Hospital Israelita Albert Einstein
Investigators
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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

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Responsible Party: Jorge Salluh, MD, PhD, D'Or Institute for Research and Education
ClinicalTrials.gov Identifier: NCT01966861     History of Changes
Other Study ID Numbers: IDOR-03-2013
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: March 2018

Keywords provided by Jorge Salluh, D'Or Institute for Research and Education:
mechanical ventilation
weaning
acute respiratory failure
weaning failure
lung ultrasound

Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases