NCT01482429

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 4, 2013

Completed
Last Updated

March 4, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

November 27, 2011

Results QC Date

January 12, 2013

Last Update Submit

January 27, 2013

Conditions

Keywords

ventilator weaningprotocol

Outcome Measures

Primary Outcomes (4)

  • Mortality

    length of ICU stay (days)

  • Duration of Weaning From Mechanical Ventilation

    days

  • Duration of Mechanical Ventilation

    days

  • Length of Intensive Care Unit Stay

    days

Study Arms (2)

Protocol-directed

EXPERIMENTAL

Discontinuation of ventilation was based in multidisciplinary protocol.

Other: Multidisciplinary weaning-ventilator protocol

Usual care

NO INTERVENTION

Discontinuation of ventilation was left entirely to the discretion of the physicians.

Interventions

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.

Also known as: Weaning-ventilator protocol
Protocol-directed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • admitted in the unit already in weaning from mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Uberlandia

Uberlândia, Minas Gerais, 38400-902, Brazil

Location

Limitations and Caveats

The lack of sedation protocol in the intensive care unit.

Results Point of Contact

Title
Liliane Barbosa da Silva Passos
Organization
Federal University of Uberlândia

Study Officials

  • Liliane Barbosa da Silva Passos

    Federal University of Uberlandia

    PRINCIPAL INVESTIGATOR
  • Thulio Marquez Cunha

    Federal University of Uberlandia

    STUDY CHAIR
  • Carlos Henrique Alves de Rezende, MD

    Federal University of Uberlandia

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2011

First Posted

November 30, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 4, 2013

Results First Posted

March 4, 2013

Record last verified: 2013-01

Locations