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Evaluation of a Systematic Approach to Weaning From Mechanical Ventilation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01482429
First Posted: November 30, 2011
Last Update Posted: March 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Liliane Barbosa da Silva Passos, Federal University of Uberlandia
Results First Submitted: January 12, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions: Weaning Failure
Complication of Respirator [Ventilator]
Intervention: Other: Multidisciplinary weaning-ventilator protocol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Adult patients hospitalized in the intensive care unit, remained on mechanical ventilation for more than 24 hours and subjected to weaning from mechanical ventilation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Protocol-directed Discontinuation of ventilation was based in multidisciplinary protocol.
Usual Care Discontinuation of ventilation was left entirely to the discretion of the physicians.

Participant Flow for 2 periods

Period 1:   Care Usual
    Protocol-directed   Usual Care
STARTED   0   269 
COMPLETED   0   96 
NOT COMPLETED   0   173 
Protocol Violation                0                172 
Lost to Follow-up                0                1 

Period 2:   Protocol
    Protocol-directed   Usual Care
STARTED   414   0 
COMPLETED   139   0 
NOT COMPLETED   275   0 
Protocol Violation                275                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Protocol-directed Discontinuation of ventilation was based in multidisciplinary protocol.
Usual Care Discontinuation of ventilation was left entirely to the discretion of the physicians.
Total Total of all reporting groups

Baseline Measures
   Protocol-directed   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 139   96   235 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.9  (20.18)   43.5  (17.89)   47.28  (19.50) 
Gender 
[Units: Participants]
     
Female   38   33   71 
Male   101   63   164 
Region of Enrollment 
[Units: Participants]
     
Brazil   139   96   235 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mortality   [ Time Frame: length of ICU stay (days) ]

2.  Primary:   Duration of Weaning From Mechanical Ventilation   [ Time Frame: days ]

3.  Primary:   Duration of Mechanical Ventilation   [ Time Frame: days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Primary:   Length of Intensive Care Unit Stay   [ Time Frame: days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The lack of sedation protocol in the intensive care unit.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Liliane Barbosa da Silva Passos
Organization: Federal University of Uberlândia
phone: 553432182150
e-mail: lilibsp@yahoo.com.br



Responsible Party: Liliane Barbosa da Silva Passos, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT01482429     History of Changes
Other Study ID Numbers: Desmame
First Submitted: November 27, 2011
First Posted: November 30, 2011
Results First Submitted: January 12, 2013
Results First Posted: March 4, 2013
Last Update Posted: March 4, 2013