Trial Outcomes & Findings for SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation (NCT NCT03128931)
NCT ID: NCT03128931
Last Updated: 2022-04-07
Results Overview
EEG signals will be collected using SedLine sensor for product development under different anesthesia and sedation conditions.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Duration of surgery
Results posted on
2022-04-07
Participant Flow
Participant milestones
| Measure |
Test Group
The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor .
Pediatric SedLine forehead EEG sensor: Pediatric EEG sensor.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Test Group
The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor .
Pediatric SedLine forehead EEG sensor: Pediatric EEG sensor.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Equipment Issues
|
3
|
Baseline Characteristics
SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
Baseline characteristics by cohort
| Measure |
Test Group
n=41 Participants
The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor .
Pediatric SedLine forehead EEG sensor: Pediatric EEG sensor.
|
|---|---|
|
Age, Categorical
<=18 years
|
41 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Duration of surgeryEEG signals will be collected using SedLine sensor for product development under different anesthesia and sedation conditions.
Outcome measures
| Measure |
Test Group
n=41 Participants
The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor .
Pediatric SedLine forehead EEG sensor: Pediatric EEG sensor.
|
|---|---|
|
Number of Participants For Whom the EEG Data Collection Was Completed
|
41 Participants
|
Adverse Events
Test Group
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
- Publication restrictions are in place
Restriction type: GT60