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

NCT ID: NCT01966861

Last Updated: 2018-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-05-31

Brief Summary

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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

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Conditions

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Acute Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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usual care

Weaning as protcolised by the units' daily practice (SBT)

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type EXPERIMENTAL

weaning guided by LUS (lung ultrasound)

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sirio-Libanes

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role collaborator

D'Or Institute for Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Jorge Salluh

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jorge IF Salluh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

D'Or Institute for Research and Education

Luiz M Malbouisson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Fabiola Prior, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Julio Neves, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital da Bahia

Jean-Jacques Rouby, MD

Role: STUDY_CHAIR

Paris University

Locations

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D'OR Institute for Research and Education

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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IDOR-03-2013

Identifier Type: -

Identifier Source: org_study_id

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