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Funding
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To compare continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in supine position.
Analysis of number and magnitude of BP changes Adjust endpoint calculation definitions and methods based on this lead in results Estimate sample size for main study Demonstration of capability to quantify and annotate interference in the arterial line signal and detect and changes in patient orientation Parallel recording of SentiCor-300 PPG sensor
Main study:
Validate SentiCor-300 noninvasive blood pressure against direct arterial pressure measurements.
Up to 200 (10 run-in, the balance- study) Run in phase will be performed with Senticor-100, data will be used for sample size estimation of balance study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accuracy of Continuous Noninvasive Blood Pressure at Various Stages of Anesthesia | To compare noninvasive continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in various positions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SentiCor-300 | Device | Continuous blood pressure measurement with the SentiCor-300. |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy | The difference between SentiCor-300 and the actual intra-arterial blood pressure for systolic and diastolic pressures. | During hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| Change | Comparison of continuous arterial pressures obtained from the SentiCor-300 with direct intra-arterial blood pressure measurements during hemodynamic changes at various stages of anesthesia (such as induction, laryngoscopy, maintenance, emergence, and recovery) and after emergence in various postures and positions. | During hospital admission |
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Inclusion Criteria:
Exclusion criteria:
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Consenting adults scheduled for elective major surgery that requires an arterial catheter will be recruited into the study. There will be no restriction on race or ethnicity.
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| Name | Affiliation | Role |
|---|---|---|
| Alparslan Turan, MD | The Cleveland Clinic | Principal Investigator |
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| Calibration Duration | To determine how long an oscillometric calibration of the SentiCor-300 lasts. | During hospital admission |
| Gender and Fitzpatrick index | To compare perform class analysis on accuracy versus gender and Fitzpatrick index. | During hospital admission |