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The primary objective of this research is to collect data to develop an algorithm for continuous, non-inflating measurement of absolute, long-term Blood Pressure using the CS6BP device and to evaluate the safety of the CS6BP.
The study will take place in the ICU (Intensive Care Unit) on non-anesthetized subjects with an arterial line inserted into the radial artery. The CS6BP non-invasive continuous recording will be collected parallel to an invasive arterial line recording. ECG data that was recorded in the ICU will be collected as well.
The study will include up to 80 subjects.
The subject may be measured by the CS6BP device more than once to check reproducibility. The first measurement may take up to 24h; Subsequent measurements may take up to 5h. All the data analysis will be done offline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood pressure monitor | Experimental | The CS6BP device will be placed on non-anesthetized subjects in the ICU (Intensive Care Unit) with arterial line placement in the radial artery. The first measurement will be for up to 24h; subsequent measures will be up to 5h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arterial LIne | Device | Continuous non-invasive recording of CS6BP will be taken parallel to the recording of an invasive arterial line. ECG data recorded in the ICU will also be collected. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of CardiacSense 1BP: Incidence and severity of device related Adverse Events | Incidence and severity of device related Adverse Events | measurement time (up to 24 hours) |
| Collection of data from CardicacSense1BP measurements for algorithm development | CardicacSense1BP data will be collected in parallel with blood pressure data from ICU a- line . | measurement time (up to 24 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benita Lanzer | Contact | 972546861500 | benita.lanzer@ocardiacsense.com | |
| Liat Shemesh | Contact | liat.shemesh@cardiacsense.com |
| Name | Affiliation | Role |
|---|---|---|
| Adi Nimrod, MD | Director Intensive Care Unit, Tel-Aviv Sourasky Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sourasky Medical Center | Recruiting | Tel Aviv | 62431 | Israel |
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| ID | Term |
|---|---|
| D062666 | Vascular Access Devices |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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Non-anaesthetized subjects in the ICU (Intensive Care Unit) or in the CICU (Cardiac Intensive Care Unit) with arterial line placement in the radial artery.
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