Caretaker vs. Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock
- Conditions
- Blood Pressure
- Interventions
- Device: Caretaker
- Registration Number
- NCT03933722
- Lead Sponsor
- The Cooper Health System
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Caretaker Caretaker Comparing blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Cooper University Hospital
🇺🇸Camden, New Jersey, United States