Blood Pressure
Conditions
Brief summary
Caretaker vs. Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock
Detailed description
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).
Interventions
DEVICECaretaker
Application of Caretaker device to subjects that have septic shock and that have an invasive arterial pressure monitor placed.
Sponsors
The Cooper Health System
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admitted with septic shock, with or without vasopressor support needed. * Greater than or equal to 18 years of age. * Have an arterial catheter already in place.
Exclusion criteria
* No arterial catheter in place. * Contraindication to the application of the Caretaker device due to pre-existing finger injury. * Patients in whom use of a BP cuff is contraindicated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an intra-arterial pressure catheter. | 20 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an upper arm cuff. | 20 minutes | 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. |
Countries
United States
Outcome results
None listed