Trial Outcomes & Findings for Rest After Spontaneous Breathing Trial for Prevention of Post-extubation Failure (NCT NCT01915563)

NCT ID: NCT01915563

Last Updated: 2019-07-01

Results Overview

Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 470 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2019-07-01

Participant Flow

Slight number of patients were enrolled after reaching the planned sample due to information delay.

Participant milestones

Measure	SBT and Extubation After a SBT patients will be extubated as usual	SBT and Rest 60 Min Before Extubation After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation REST: After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation.
Overall Study STARTED	243	227
Overall Study COMPLETED	243	227
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rest After Spontaneous Breathing Trial for Prevention of Post-extubation Failure

Baseline characteristics by cohort

Measure	SBT and Extubation n=243 Participants After a SBT patients will be extubated as usual	SBT and Rest 60 Min Before Extubation n=227 Participants After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation REST: After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation.	Total n=470 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 15 • n=5 Participants	65 years STANDARD_DEVIATION 15 • n=7 Participants	63.5 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Region of Enrollment Spain	243 participants n=5 Participants	227 participants n=7 Participants	470 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Development of predefined criteria of respiratory insufficiency within 48 hours after scheduled extubation

Outcome measures

Measure	SBT and Extubation n=243 Participants After a SBT patients will be extubated as usual	SBT and Rest 60 Min Before Extubation n=227 Participants After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation REST: After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation.
Number of Patients With Extubation Failure	58 Participants	24 Participants

SECONDARY outcome

Timeframe: up to 3 months

Outcome measures

Measure	SBT and Extubation n=243 Participants After a SBT patients will be extubated as usual	SBT and Rest 60 Min Before Extubation n=227 Participants After SBT patients will be reconnected to mechanical ventilation during 60 min before extubation REST: After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation.
ICU Mortality	12 Participants	10 Participants

Adverse Events

SBT and Extubation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SBT and Rest 60 Min Before Extubation

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

Dr Rafael Fernandez

Althaia Xarxa Assistencial Universitaria de Manresa

Phone: 34.8732550

Email: rfernandezf@althaia.cat

Results disclosure agreements

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