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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SedLine Vs Comparator Test Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SedLine Vs Comparator Test Group | Device | Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Sedation Indices Performance Across Anesthesia Range | The correlation was computed using 1 min average values between the PSi and the comparator's sedation index. | Duration of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33823811 | Derived | Jones JH, Nittur VR, Fleming N, Applegate RL 2nd. Simultaneous comparison of depth of sedation performance between SedLine and BIS during general anesthesia using custom passive interface hardware: study protocol for a prospective, non-blinded, non-randomized trial. BMC Anesthesiol. 2021 Apr 6;21(1):105. doi: 10.1186/s12871-021-01326-5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation of Sedation Indices Performance Across Anesthesia Range | The correlation was computed using 1 min average values between the PSi and the comparator's sedation index. | Due to the complexity of data collection, complete data for analysis was available from 61 subjects. | Posted | Number | 95% Confidence Interval | Pearson r | Duration of surgery |
|
|
Approximately 8 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Petechial Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cristina Johnson | Masimo Corporation | 949-297-7000 | ClinicalResearchDept@masimo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2021 | Mar 11, 2022 | Prot_SAP_000.pdf |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants |
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| 0 |
| 100 |
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| 100 |
| 1 |
| 100 |
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