Trial Outcomes & Findings for EEG Data Collection to Evaluate New Patient State Index Performance (NCT NCT02954952)
NCT ID: NCT02954952
Last Updated: 2019-08-22
Results Overview
Compare the length of time from when the anesthesia has ended to the time of Return of Consciousness (ROC) between the PSI 1.X group and the PSI 2.X group.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
From the end of anesthesia to the time of Return of Consciousness
Results posted on
2019-08-22
Participant Flow
Participant milestones
| Measure |
Standard of Care (Baseline)
Subjects will receive the Sedline sensor. The anesthesiologist will be blinded to the PSI Rev 1.X score and the raw EEG data from the Masimo device. Anesthesia management will be in accordance with standard of care protocols and procedures.
PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement.
|
PSI Rev 1.X
The anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X).
PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement.
|
PSI Rev 2.X
The anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X).
PSI Rev 2.X: PSI Rev 2.X is a newer version of the PSI measurement.
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
5
|
3
|
|
Overall Study
COMPLETED
|
35
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Standard of Care (Baseline)
Subjects will receive the Sedline sensor. The anesthesiologist will be blinded to the PSI Rev 1.X score and the raw EEG data from the Masimo device. Anesthesia management will be in accordance with standard of care protocols and procedures.
PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement.
|
PSI Rev 1.X
The anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X).
PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement.
|
PSI Rev 2.X
The anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X).
PSI Rev 2.X: PSI Rev 2.X is a newer version of the PSI measurement.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
No data collected
|
0
|
1
|
0
|
Baseline Characteristics
EEG Data Collection to Evaluate New Patient State Index Performance
Baseline characteristics by cohort
| Measure |
Standard of Care (Baseline)
n=36 Participants
Subjects will receive the Sedline sensor. The anesthesiologist will be blinded to the PSI Rev 1.X score and the raw EEG data from the Masimo device. Anesthesia management will be in accordance with standard of care protocols and procedures.
PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement.
|
PSI Rev 1.X
n=5 Participants
The anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X).
PSI Rev 1.X: PSI Rev 1.X is an older version of the PSI measurement.
|
PSI Rev 2.X
n=3 Participants
The anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X).
PSI Rev 2.X: PSI Rev 2.X is a newer version of the PSI measurement.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 15.5 • n=7 Participants
|
67 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
22 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
13 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
27 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From the end of anesthesia to the time of Return of ConsciousnessPopulation: Data were not collected.
Compare the length of time from when the anesthesia has ended to the time of Return of Consciousness (ROC) between the PSI 1.X group and the PSI 2.X group.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completionCompare the total amount of anesthesia drug used between the PSI 1.X group and the PSI 2.X group.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through study completionCompare the frequency of somatic events between the PSI 1.X group and the PSI 2.X group.
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care (Baseline)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PSI Rev 1.X
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PSI Rev 2.X
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
Results disclosure agreements
- Principal investigator is a sponsor employee The PI can initiate publication after 12 months of study completion or early termination (whichever is applicable). The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER