Trial Outcomes & Findings for Comparison Between Two Methods of Spontaneous Breathing Trial (SBT) (NCT NCT00400881)
NCT ID: NCT00400881
Last Updated: 2017-06-09
Results Overview
Weaning time was determined as number of days from the day of the first SBT(spontaneous breathing trial) to the day of extubation. All patients were followed until extubation.
COMPLETED
NA
122 participants
days
2017-06-09
Participant Flow
Participant milestones
| Measure |
CPAP (Continuous Positive Airway Pressure)
CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
|
Automatic Tube Compensation (ATC)
ATC mode of ventilation (intervention, not-standard mode)
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
60
|
|
Overall Study
COMPLETED
|
62
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison Between Two Methods of Spontaneous Breathing Trial (SBT)
Baseline characteristics by cohort
| Measure |
CPAP (Continuous Positive Airway Pressure)
n=62 Participants
CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
|
Automatic Tube Compensation (ATC)
n=60 Participants
ATC mode of ventilation (intervention, not-standard mode)
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
105 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 19 • n=93 Participants
|
52 years
STANDARD_DEVIATION 20 • n=4 Participants
|
51 years
STANDARD_DEVIATION 20 • n=27 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
79 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=93 Participants
|
60 participants
n=4 Participants
|
122 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: daysPopulation: All patients completing the SBT were analysed except for two patients in each group that were excluded from analysis per protocol due to re-intubation due to upper airway obstruction.
Weaning time was determined as number of days from the day of the first SBT(spontaneous breathing trial) to the day of extubation. All patients were followed until extubation.
Outcome measures
| Measure |
CPAP
n=60 Participants
Continuous Positive Airway Pressure
|
ATC (ATComp)
n=58 Participants
Automatic Tube Compensation
|
|---|---|---|
|
Duration of Weaning Time
|
0.18 days
Standard Deviation 0.5
|
0.05 days
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: daysPopulation: Analysis per protocol. All patients completing the SBT were analysed except for two patients in each group that were excluded from analysis per protocol due to re-intubation due to upper airway obstruction.
Duration in days from day of intubation to day of extubation.
Outcome measures
| Measure |
CPAP
n=60 Participants
Continuous Positive Airway Pressure
|
ATC (ATComp)
n=58 Participants
Automatic Tube Compensation
|
|---|---|---|
|
Duration of Mechanical Ventilation
|
4.9 days
Standard Deviation 3.4
|
5.1 days
Standard Deviation 4.2
|
Adverse Events
CPAP (Continuous Positive Airway Pressure)
Automatic Tube Compensation (ATC)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place