Trial Outcomes & Findings for Extubation Readiness and Neuroventilatory Efficiency After Acute Respiratory Failure (NCT NCT01065428)
NCT ID: NCT01065428
Last Updated: 2011-08-31
Results Overview
NVE is the ratio of tidal volume and diaphragm electrical activity (Vt/EAdi).It is a value describing how effective a patient's breathing is.
COMPLETED
52 participants
at 30 minutes of the spontaneous breathing trials (SBT)
2011-08-31
Participant Flow
In a 20 beds general ICU of a teaching hospital, from December 2008 to May 2010, 52 patients , mechanically ventilated for \> 24 h, were included when they deemed ready for extubation by the clinical team and fulfilled established weaning criteria.
Nasogastric tube Eligible patient was replaced with a modified EAdi catheter (Maquet, Solna, Sweden). Then the patients were switched to a Servo-i ventilator capable of processing signals of EAdi automatically.
Participant milestones
| Measure |
Weaning Failure
Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
|
Weaning Successful
Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
35
|
|
Overall Study
COMPLETED
|
17
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extubation Readiness and Neuroventilatory Efficiency After Acute Respiratory Failure
Baseline characteristics by cohort
| Measure |
Weaning Failure
n=17 Participants
Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
|
Weaning Successful
n=35 Participants
Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
|
Total
n=52 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
|
1 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Age Continuous
|
76.0 years
STANDARD_DEVIATION 6.4 • n=93 Participants
|
65.2 years
STANDARD_DEVIATION 18.5 • n=4 Participants
|
68.8 years
STANDARD_DEVIATION 16.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Region of Enrollment
China
|
17 participants
n=93 Participants
|
35 participants
n=4 Participants
|
52 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: at 30 minutes of the spontaneous breathing trials (SBT)NVE is the ratio of tidal volume and diaphragm electrical activity (Vt/EAdi).It is a value describing how effective a patient's breathing is.
Outcome measures
| Measure |
Weaning Failure
n=17 Participants
Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
|
Weaning Successful
n=35 Participants
Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
|
|---|---|---|
|
Neuroventilatory Efficiency (NVE)
|
17.6 ml/uV
Standard Deviation 10.7
|
39.9 ml/uV
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: at 30 minutes of the spontaneous breathing trials (SBT)NME is the ratio between inspiratory pressure generation and EAdi (Paw/EAdi).
Outcome measures
| Measure |
Weaning Failure
n=17 Participants
Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
|
Weaning Successful
n=35 Participants
Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
|
|---|---|---|
|
Neuromechanical Efficiency (NME)
|
1.13 cmH2O/uV
Standard Deviation 0.71
|
1.77 cmH2O/uV
Standard Deviation 0.79
|
Adverse Events
Weaning Failure
Weaning Successful
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Haibo Qiu; Dr. Christer Sinderby
Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine, China
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place