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

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ClinicalTrials.gov Identifier: NCT03933722
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
The Cooper Health System

Tracking Information
First Submitted Date April 18, 2019
First Posted Date May 1, 2019
Last Update Posted Date May 1, 2019
Actual Study Start Date February 4, 2019
Estimated Primary Completion Date February 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2019)
Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an intra-arterial pressure catheter. [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 30, 2019)
Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an upper arm cuff. [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Caretaker vs. Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock
Official Title Comparison of Noninvasive Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock
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).
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults ages > 18 who have septic shock and have an arterial line monitor in place.
Condition Blood Pressure
Intervention Device: Caretaker
Application of Caretaker device to subjects that have septic shock and that have an invasive arterial pressure monitor placed.
Study Groups/Cohorts Caretaker
Comparing blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker).
Intervention: Device: Caretaker
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 30, 2019)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 4, 2021
Estimated Primary Completion Date February 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Irwin Gratz, MD 856-342-2000 gratz-irwin@cooperhealth.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03933722
Other Study ID Numbers 18-180EX
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement Not Provided
Responsible Party The Cooper Health System
Study Sponsor The Cooper Health System
Collaborators Not Provided
Investigators
Principal Investigator: Irwin Gratz, MD The Cooper Health System
PRS Account The Cooper Health System
Verification Date April 2019