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Caretaker vs. Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock
The aim of this study is to compare blood pressure obtained using routine blood pressure sphygmomanometer, in patients with invasive arterial pressure monitoring that have septic shock, to a non-invasive device that continuously monitors central blood pressure (CareTaker).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caretaker | Comparing blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caretaker | Device | Application of Caretaker device to subjects that have septic shock and that have an invasive arterial pressure monitor placed. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an intra-arterial pressure catheter. | The primary outcome measure will be the average difference in systolic and diastolic blood pressure measurements between the investigational device (Caretaker) and the reference (intra-arterial catheter pressure) in subjects that have septic shock. In line with blood pressure validation guidelines, we will obtain multiple investigational-reference measurement pairs in each subject (20 minutes total) and will average the difference over all pairs from all subjects. | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an upper arm cuff. | Secondary outcome measure will be the average difference in systolic and diastolic blood pressure measurements between the investigational device (Caretaker) and a brachial cuff in subjects that have septic shock. In line with blood pressure validation guidelines, we will obtain multiple investigational-reference measurement pairs in each subject (4 pairs over 20 minutes) and will average the difference over all pairs from all subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults ages > 18 who have septic shock and have an arterial line monitor in place.
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| Name | Affiliation | Role |
|---|---|---|
| Irwin Gratz, MD | The Cooper Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Hospital | Camden | New Jersey | 08031 | United States |
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| 20 minutes |