Trial Outcomes & Findings for Extubation With or Without Spontaneous Breathing Trial (NCT NCT01020773)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

67 participants

Primary outcome timeframe

13 months

Results posted on

2009-11-26

Participant milestones
Measure	SBT Group In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.	No-SBT Group In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
Overall Study STARTED	35	32
Overall Study COMPLETED	31	29
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal
Measure	SBT Group In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.	No-SBT Group In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
Overall Study Withdrawal by Subject	4	3

Extubation With or Without Spontaneous Breathing Trial

Baseline characteristics by cohort
Measure	SBT Group n=35 Participants In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.	No-SBT Group n=32 Participants In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	18 Participants n=7 Participants	38.0 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	13 Participants n=7 Participants	28.0 Participants n=5 Participants
Age Continuous	58.9 years STANDARD_DEVIATION 16.3 • n=5 Participants	56.7 years STANDARD_DEVIATION 18.0 • n=7 Participants	57.9 years STANDARD_DEVIATION 17.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25.0 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	20 Participants n=7 Participants	42.0 Participants n=5 Participants

Timeframe: 13 months

Outcome measures
Measure	SBT Group n=31 Participants In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.	No-SBT Group n=29 Participants In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
Number of Participants With Successful Extubation, Reintubation and in Hospital Mortality Successful extubation	28 participants	29 participants
Number of Participants With Successful Extubation, Reintubation and in Hospital Mortality Reintubation	3 participants	3 participants
Number of Participants With Successful Extubation, Reintubation and in Hospital Mortality In hospital mortality	3 participants	4 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Beijing Shijitan Hospital

Phone: 86-010-63926385