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

Blood Pressure Clinical Trial

Official title:

Comparison of Noninvasive Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03933722
• Other study ID #: 18-180EX
• Status: Active, not recruiting
• Start date: February 4, 2019
• Est. completion date: February 5, 2024

Study information

• Verified date: February 2024
• Source: The Cooper Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	20 minutes