Back to results

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

Primary Purpose

Acute Respiratory Failure

Status

Unknown status

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

weaning guided by LUS (lung ultrasound)

About this trial

This is an interventional prevention trial for Acute Respiratory Failure focused on measuring mechanical ventilation, weaning, acute respiratory failure, weaning failure, lung ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

D'OR Institute for Research and Education

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

usual care

Weaning guided by lung ultrasound

Arm Description

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

Predictive early signs of respiratory distress are assessed by lung ultrasound and if found will trigger protocolised intervention (eg- fluid balance,diuretics, thoracocentesis)

Outcomes

Primary Outcome Measures

Respiratory distress requiring re-intubation or non-invasive ventilation

Secondary Outcome Measures

28-day mortality

Hospital Mortality

Adverse events

Renal dysfunction, complications of thoracocentesis, hydro-electrolite changes, hypotension

Full Information

NCT ID

NCT01966861

First Posted

October 15, 2013

Last Updated

March 1, 2018

Sponsor

D'Or Institute for Research and Education

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01966861

Brief Title

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

Acronym

WEANLUS-BR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

D'Or Institute for Research and Education

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Failure

Keywords

mechanical ventilation, weaning, acute respiratory failure, weaning failure, lung ultrasound

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

usual care

Arm Type

No Intervention

Arm Description

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

Arm Title

Weaning guided by lung ultrasound

Arm Type

Experimental

Arm Description

Predictive early signs of respiratory distress are assessed by lung ultrasound and if found will trigger protocolised intervention (eg- fluid balance,diuretics, thoracocentesis)

Intervention Type

Other

Intervention Name(s)

weaning guided by LUS (lung ultrasound)

Intervention Description

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 Measure Information:

Title

Respiratory distress requiring re-intubation or non-invasive ventilation

Time Frame

48hours

Secondary Outcome Measure Information:

Title

28-day mortality

Time Frame

28 days

Title

Hospital Mortality

Time Frame

Hospital death/discharge (up to 60 days)

Title

Adverse events

Description

Renal dysfunction, complications of thoracocentesis, hydro-electrolite changes, hypotension

Time Frame

48h

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: