Weaning FailureNCT01482429
Evaluation of a Systematic Approach to Weaning From Mechanical Ventilation
A study testing Multidisciplinary weaning-ventilator protocol in people with Weaning Failure and Complication of Respirator [Ventilator], run by Federal University of Uberlandia at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning Failure, Complication of Respirator [Ventilator]
- What is being tested?
- Multidisciplinary weaning-ventilator protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- remain in mechanical ventilation for more than 24 hours
- begin weaning from mechanical ventilation
Who cannot join
- admitted in the unit already in weaning from mechanical ventilation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Uberlandia
Uberlândia, Minas Gerais, 38400-902
About this study
Official title: Implantation of a Multidisciplinary Ventilator-weaning Protocol in a Intensive Care Unit of Teaching Hospital of Federal University of Uberlandia
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.
- Being tested
- Multidisciplinary weaning-ventilator protocol
- Keywords
- ventilator weaning, protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary weaning-ventilator protocolOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Protocol-directed | Experimental | Discontinuation of ventilation was based in multidisciplinary protocol. Receives: Other: Multidisciplinary weaning-ventilator protocol |
| Usual care | No intervention | Discontinuation of ventilation was left entirely to the discretion of the physicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: length of ICU stay (days)
Duration of Weaning From Mechanical Ventilation
Measured: days
Duration of Mechanical Ventilation
Measured: days
Length of Intensive Care Unit Stay
Measured: days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Weaning FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liliane Barbosa da Silva Passos, Federal University of Uberlandia
- Investigators
- Liliane Barbosa da Silva Passos, Principal investigator, Federal University of UberlandiaThulio Marquez Cunha, Study chair, Federal University of UberlandiaCarlos Henrique Alves de Rezende, MD, Study chair, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482429
- Sponsor's protocol ID
- Desmame
- Status last verified
- Jan 2013
- First submitted
- 27 Nov 2011
- Last updated
- 4 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of a Multidisciplinary Ventilator-weaning Protocol in a Intensive Care Unit of Teaching Hospital of Federal University of Uberlandia
- ClinicalTrials.gov ID
- NCT01482429
- Acronym / sponsor ID
- Desmame
- Keywords
- ventilator weaning, protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Posted 4 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocol-directed | Experimental | Other: Multidisciplinary weaning-ventilator protocolDiscontinuation of ventilation was based in multidisciplinary protocol. |
| Usual care | No intervention | –Discontinuation of ventilation was left entirely to the discretion of the physicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- remain in mechanical ventilation for more than 24 hours
- begin weaning from mechanical ventilation
Key exclusion criteria (1 listed)
- admitted in the unit already in weaning from mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary weaning-ventilator protocolAlso: Weaning-ventilator protocolWe 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 | Protocol-directed |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary weaning-ventilator protocol in people with Weaning Failure and Complication of Respirator [Ventilator], run by Federal University of Uberlandia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: length of ICU stay (days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2013.