Trial Outcomes & Findings for Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia (NCT NCT03865316)

Last Updated: 2022-04-11

Results Overview

The correlation was computed using 1 min average values between the PSi and the comparator's sedation index.

Recruitment status

COMPLETED

Study phase

Target enrollment

108 participants

Primary outcome timeframe

Duration of surgery

Results posted on

2022-04-11

Participant milestones
Measure	SedLine Vs Comparator Test Group SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
Overall Study STARTED	108
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	8

Reasons for withdrawal
Measure	SedLine Vs Comparator Test Group SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
Overall Study Procedure Cancelled	4
Overall Study Equipment failure	4

Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia

Baseline characteristics by cohort
Measure	SedLine Vs Comparator Test Group n=100 Participants SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=5 Participants
Age, Categorical >=65 years	37 Participants n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants
Race/Ethnicity, Customized African American	5 participants n=5 Participants
Race/Ethnicity, Customized White	74 participants n=5 Participants
Race/Ethnicity, Customized American Indian	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Other	5 participants n=5 Participants
Race/Ethnicity, Customized Not reported	14 participants n=5 Participants
Region of Enrollment United States	100 Participants n=5 Participants

Timeframe: Duration of surgery

Population: Due to the complexity of data collection, complete data for analysis was available from 61 subjects.

The correlation was computed using 1 min average values between the PSi and the comparator's sedation index.

Outcome measures
Measure	SedLine Vs Comparator Test Group n=61 Participants SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
Correlation of Sedation Indices Performance Across Anesthesia Range	0.8314 Pearson r Interval 0.824 to 0.8385

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	SedLine Vs Comparator Test Group n=100 participants at risk SedLine Vs Comparator Test Group: Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
Skin and subcutaneous tissue disorders Petechial Rash	1.0% 1/100 • Number of events 1 • Approximately 8 hours.

Masimo Corporation

Phone: 949-297-7000

Restriction type: GT60