Evaluation of a Systematic Approach to Weaning From Mechanical Ventilation
This study has been completed.
Sponsor:
Federal University of Uberlandia
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
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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
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 May 19, 2013