Trials / Completed
CompletedNCT03865316
Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- Masimo Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to compare the performance of Masimo's SedLine and the comparator's device systems during surgery. Relative accuracy of the individual depth of sedation indices will be compared.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SedLine Vs Comparator Test Group | Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system. |
Timeline
- Start date
- 2019-01-25
- Primary completion
- 2021-03-11
- Completion
- 2021-03-11
- First posted
- 2019-03-06
- Last updated
- 2022-04-11
- Results posted
- 2022-04-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03865316. Inclusion in this directory is not an endorsement.