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Evaluation of a Systematic Approach to Weaning From Mechanical Ventilation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01482429
First Posted: November 30, 2011
Last Update Posted: March 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Liliane Barbosa da Silva Passos, Federal University of Uberlandia
  Purpose

Prolongation of mechanical ventilation poses serious personal and financial threats to healthcare consumers.

The investigators objectives are create and implement an multidisciplinary evidenced-based ventilator-weaning protocol to assess whether a systematic approach compared with the physician's judgment only decreases time spent on the ventilator, complications of mechanical ventilation and length of stay in critical care unit.


Condition Intervention
Weaning Failure Complication of Respirator [Ventilator] Other: Multidisciplinary weaning-ventilator protocol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Implantation of a Multidisciplinary Ventilator-weaning Protocol in a Intensive Care Unit of Teaching Hospital of Federal University of Uberlandia

Further study details as provided by Liliane Barbosa da Silva Passos, Federal University of Uberlandia:

Primary Outcome Measures:
  • Mortality [ Time Frame: length of ICU stay (days) ]
  • Duration of Weaning From Mechanical Ventilation [ Time Frame: days ]
  • Duration of Mechanical Ventilation [ Time Frame: days ]
  • Length of Intensive Care Unit Stay [ Time Frame: days ]

Enrollment: 235
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protocol-directed
Discontinuation of ventilation was based in multidisciplinary protocol.
Other: Multidisciplinary weaning-ventilator protocol
We implemented a multidisciplinary protocol for weaning from mechanical ventilation.This consist of a daily screening for readiness, performing a spontaneous breathing test, evaluation of signs of intolerance and decision on extubation.
Other Name: Weaning-ventilator protocol
No Intervention: Usual care
Discontinuation of ventilation was left entirely to the discretion of the physicians.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • remain in mechanical ventilation for more than 24 hours
  • begin weaning from mechanical ventilation

Exclusion Criteria:

  • admitted in the unit already in weaning from mechanical ventilation
  Contacts and Locations
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): NCT01482429


Locations
Brazil
Federal University of Uberlandia
Uberlandia, Minas Gerais, Brazil, 38400-902
Sponsors and Collaborators
Federal University of Uberlandia
Investigators
Principal Investigator: Liliane Barbosa da Silva Passos Federal University of Uberlandia
Study Chair: Thulio Marquez Cunha Federal University of Uberlandia
Study Chair: Carlos Henrique Alves de Rezende, MD Federal University of Uberlandia
  More Information

Responsible Party: Liliane Barbosa da Silva Passos, Principal Investigator, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT01482429     History of Changes
Other Study ID Numbers: Desmame
First Submitted: November 27, 2011
First Posted: November 30, 2011
Results First Submitted: January 12, 2013
Results First Posted: March 4, 2013
Last Update Posted: March 4, 2013
Last Verified: January 2013

Keywords provided by Liliane Barbosa da Silva Passos, Federal University of Uberlandia:
ventilator weaning
protocol