Evaluation of a Systematic Approach to Weaning From Mechanical Ventilation

This study has been completed.

Sponsor:

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

History of Changes

Results First Received: January 12, 2013

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: 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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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
Number of Participants [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

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1. Primary:

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

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2. Primary:

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

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3. Primary:

Duration of Mechanical Ventilation [ Time Frame: days ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

4. Primary:

Length of Intensive Care Unit Stay [ Time Frame: days ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

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.

Results Point of Contact:

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

No publications provided

Responsible Party:	Liliane Barbosa da Silva Passos, 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

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