Trial Outcomes & Findings for Evaluation of a Systematic Approach to Weaning From Mechanical Ventilation (NCT NCT01482429)

NCT ID: NCT01482429

Last Updated: 2013-03-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 235 participants
• Primary outcome timeframe: length of ICU stay (days)
• Results posted on: 2013-03-04

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.

Participant milestones

Measure	Protocol-directed Discontinuation of ventilation was based in multidisciplinary protocol.	Usual Care Discontinuation of ventilation was left entirely to the discretion of the physicians.
Care Usual STARTED	0	269
Care Usual COMPLETED	0	96
Care Usual NOT COMPLETED	0	173
Protocol STARTED	414	0
Protocol COMPLETED	139	0
Protocol NOT COMPLETED	275	0

Reasons for withdrawal

Measure	Protocol-directed Discontinuation of ventilation was based in multidisciplinary protocol.	Usual Care Discontinuation of ventilation was left entirely to the discretion of the physicians.
Care Usual Protocol Violation	0	172
Care Usual Lost to Follow-up	0	1
Protocol Protocol Violation	275	0

Baseline Characteristics

Evaluation of a Systematic Approach to Weaning From Mechanical Ventilation

Baseline characteristics by cohort

Measure	Protocol-directed n=139 Participants Discontinuation of ventilation was based in multidisciplinary protocol.	Usual Care n=96 Participants Discontinuation of ventilation was left entirely to the discretion of the physicians.	Total n=235 Participants Total of all reporting groups
Age Continuous	49.9 years STANDARD_DEVIATION 20.18 • n=5 Participants	43.5 years STANDARD_DEVIATION 17.89 • n=7 Participants	47.28 years STANDARD_DEVIATION 19.50 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	33 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	63 Participants n=7 Participants	164 Participants n=5 Participants
Region of Enrollment Brazil	139 participants n=5 Participants	96 participants n=7 Participants	235 participants n=5 Participants

PRIMARY outcome

Timeframe: length of ICU stay (days)

Population: Overall

Outcome measures

Measure	Protocol-directed n=139 Participants Discontinuation of ventilation was based in multidisciplinary protocol.	Usual Care n=96 Participants Discontinuation of ventilation was left entirely to the discretion of the physicians.
Mortality	10 participants	14 participants

PRIMARY outcome

Timeframe: days

Population: overall

Outcome measures

Measure	Protocol-directed n=139 Participants Discontinuation of ventilation was based in multidisciplinary protocol.	Usual Care n=96 Participants Discontinuation of ventilation was left entirely to the discretion of the physicians.
Duration of Weaning From Mechanical Ventilation	3.6 days Standard Deviation 5.49	6.8 days Standard Deviation 9.45

PRIMARY outcome

Timeframe: days

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: days

Outcome measures

Outcome data not reported

Adverse Events

Protocol-directed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Liliane Barbosa da Silva Passos

Federal University of Uberlândia

Phone: 553432182150

Email: lilibsp@yahoo.com.br

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place