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

NCT03933722 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 18-180EX
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an upper arm cuff.

  20 minutes

Study Arms (1)

Caretaker

Comparing blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker).

Device: Caretaker

Interventions

Caretaker DEVICE

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

Caretaker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults ages \> 18 who have septic shock and have an arterial line monitor in place.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08031, United States

Location

Study Officials

• Irwin Gratz, MD

  The Cooper Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: May 1, 2019
• Study Start: February 4, 2019
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

US (1)