Caretaker vs. Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock

The Cooper Health System40 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Blood Pressure

Interventions

CaretakerDEVICE

Application of Caretaker device to subjects that have septic shock and that have an invasive arterial pressure monitor placed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cooper University Hospital

Camden, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 20 minutes

Secondary Outcomes

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.

Time frame: 20 minutes

Data from ClinicalTrials.gov

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