Evaluation of a Systematic Approach to Weaning From Mechanical Ventilation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Liliane Barbosa da Silva Passos, Federal University of Uberlandia
ClinicalTrials.gov Identifier:
NCT01482429
First received: November 27, 2011
Last updated: January 27, 2013
Last verified: January 2013
  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: 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 Federal University of Uberlandia:

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 27, 2011
Results First Received: January 12, 2013
Last Updated: January 27, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Uberlandia:
ventilator weaning
protocol

ClinicalTrials.gov processed this record on October 20, 2014