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A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients.
A prospective, single arm data collection study evaluating a prototype ClearSight finger cuff in pediatric patients under 2 years old
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All study subjects | All study subjects will receive the ClearSight noninvasive finger cuff on one finger. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClearSight baby cuff | Device | Noninvasive device for continuous blood pressure monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proper cuff fit | The cuff fits properly on the participant's finger in at least 90% of total number of participants. Proper Fit is defined as complete overlap of the hook and loop areas attached to the cuff and the securement flap. | 30 minutes of monitoring with study devices during scheduled surgery procedure |
| Cuff remains properly fitted for the duration of the study measurement | The cuff remains properly fitted for the duration of the study measurement for at least 90% of total number of participants. | 30 minutes of monitoring with study devices during scheduled surgery procedure |
| Measurement with monitor started without errors | A measurement can be started without the monitor producing errors and a blood pressure waveform is measured in at least 60% of the attempts, unless the monitor is warning for vaso-constriction. | 30 minutes of monitoring with study devices during scheduled surgery procedure |
| Measurement stability within 10 mins | The automatic physiological calibration (Physiocal) stabilizes to intervals ≥ 30 beats within 10 minutes in at least 60% of the attempts, indicating measurement stability unless the monitor is warning for vaso-constriction. | 30 minutes of monitoring with study devices during scheduled surgery procedure |
| Early feasibility accuracy | For systolic blood pressure and diastolic blood pressure the mean value of the errors of all individual paired determinations of the ClearSight versus reference blood pressure shall be within or equal to ±5 mmHg, with a standard deviation, no greater than 8 mmHg. | 30 minutes of monitoring with study devices during scheduled surgery procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be less than 2 years of age with blood pressure monitoring as part of routine care.
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| Name | Affiliation | Role |
|---|---|---|
| Tina Abdelnour, MS, BSN | Edwards Lifesciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC, location AMC | Amsterdam | Netherlands | 1105AZ | Netherlands |
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