CClinicalTrials.gg
CompletedNCT01482429Updated Mar 4, 2013Results posted

Evaluation of a Systematic Approach to Weaning From Mechanical Ventilation

An interventional study of Multidisciplinary weaning-ventilator protocol in Weaning Failure and Complication of Respirator [Ventilator], sponsored by Federal University of Uberlandia. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-04.

Sponsored by Federal University of Uberlandia · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
235
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Weaning Failure
  • Complication of Respirator [Ventilator]

Keywords

  • ventilator weaning
  • protocol
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In context

Lead sponsor

Federal University of Uberlandia is the lead sponsor of 59 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • admitted in the unit already in weaning from mechanical ventilation
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Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
235 participants (actual)

Study arms

  • Experimental
    Protocol-directed

    Discontinuation of ventilation was based in multidisciplinary protocol.

    Other: Multidisciplinary weaning-ventilator protocol

  • No intervention
    Usual care

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

Interventions

  • OtherMultidisciplinary 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.

    Also known as: Weaning-ventilator protocol

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What researchers measure

Primary outcomes

  1. Mortality

    Time frame: length of ICU stay (days)

  2. Duration of Weaning From Mechanical Ventilation

    Time frame: days

  3. Duration of Mechanical Ventilation

    Time frame: days

  4. Length of Intensive Care Unit Stay

    Time frame: days

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Results

Posted Mar 4, 2013
Limitations and caveats
The lack of sedation protocol in the intensive care unit.

Participant flow

Adult patients hospitalized in the intensive care unit, remained on mechanical ventilation for more than 24 hours and subjected to weaning from mechanical ventilation.

Care Usual
Participant flow — Care Usual
MilestoneProtocol-directedUsual Care
Started0269
Completed096
Not completed0173
Withdrew: Protocol violation0172
Withdrew: Lost to follow-up01
Protocol
Participant flow — Protocol
MilestoneProtocol-directedUsual Care
Started4140
Completed1390
Not completed2750
Withdrew: Protocol violation2750

Outcome measures

PrimaryMortality
Time frame:
length of ICU stay (days)
Reported as:
Number · participants
Mortality
participantsProtocol-directedUsual Care
Mortality1014
Statistical analysis
  • Protocol-directed vs Usual Care · binomial test · p = 0.03
PrimaryDuration of Weaning From Mechanical Ventilation
Time frame:
days
Reported as:
Mean · days
Duration of Weaning From Mechanical Ventilation
daysProtocol-directedUsual Care
Duration of Weaning From Mechanical Ventilation3.6 ± 5.496.8 ± 9.45
Statistical analysis
  • Protocol-directed vs Usual Care · Wilcoxon (Mann-Whitney) · p = <0.0001
PrimaryDuration of Mechanical Ventilation
Time frame:
days

Results for this outcome have not been posted.

PrimaryLength of Intensive Care Unit Stay
Time frame:
days

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Protocol-directed———
Usual Care———

Baseline characteristics

Age Continuous
Age Continuous(years)Protocol-directedUsual CareTotal
Mean49.9 ± 20.1843.5 ± 17.8947.28 ± 19.50
Sex: Female, Male
Sex: Female, Male(Participants)Protocol-directedUsual CareTotal
Female383371
Male10163164
Region of Enrollment
Region of Enrollment(participants)Protocol-directedUsual CareTotal
Brazil13996235
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Study locations

1 site
  • Federal University of Uberlandia
    Uberlandia, Minas Gerais 38400-902, Brazil
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01482429
Lead sponsor
Federal University of Uberlandia
Responsible party
Liliane Barbosa da Silva Passos (Principal Investigator, Federal University of Uberlandia) — Principal investigator
First posted
Nov 30, 2011
Start date
Jan 2011
Primary completion
Jan 2012
Completion
Jan 2012
Results posted
Mar 4, 2013
Last update
Mar 4, 2013

Study contacts

Liliane Barbosa da Silva Passos
principal investigator · Federal University of Uberlandia
Thulio Marquez Cunha
study chair · Federal University of Uberlandia
Carlos Henrique Alves de Rezende, MD
study chair · Federal University of Uberlandia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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