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Study was terminated as enrollment rate did not meet the requirement of the Sponsor.
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The purpose of the study is to collect EEG data with the Masimo SedLine device along with vital signs, patient demographics, anesthetic record and surgical procedure during general anesthesia or sedation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pediatric SedLine forehead EEG sensor | Device | Pediatric EEG sensor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants For Whom the EEG Data Collection Was Completed | EEG signals will be collected using SedLine sensor for product development under different anesthesia and sedation conditions. | Duration of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucille Packard Children's Hospital | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Number of Participants For Whom the EEG Data Collection Was Completed | EEG signals will be collected using SedLine sensor for product development under different anesthesia and sedation conditions. | Posted | Count of Participants | Participants | Duration of surgery |
|
|
1 day
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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 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vikram Ramakanth | Masimo Corporation | 949-297-7416 | 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 | Nov 6, 2018 | May 28, 2020 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
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