Physiologic Signals and Signatures With the Accuryn™ Monitoring System in Intensive Care Patients (PRESCIENT)

The purpose of the study is to collect physiologic data streams with the Accuryn Monitoring System and validate the accuracy of these measurements against existing gold standards, and to track and analyze changes in these physiologic data streams to identify clinical signatures that may enable earlier diagnosis and intervention of critical conditions.

Study Overview

• Status: Completed
• Conditions: Critical Care, Intensive Care

• Study Type: Observational
• Enrollment (Actual): 76

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Significantly injured trauma ICU patients receiving a Foley catheter and transfusion

Description

Inclusion Criteria:

• Admission to the hospital with trauma (including burn)
• Anticipated ICU stay of at least 72 hours
• Anticipated transfusion of ≥1 unit blood products (pRBC's, platelets, and/or plasma) within the first 24 hours of hospitalization, and/or a current diagnosis of sepsis/septic shock, and/or ICU admission primarily for burn
• Anticipated requirement for a urinary bladder catheter for ≥ 72 hours

Exclusion Criteria:

• Inability to receive a 16F urinary bladder catheter
• Significant bladder or urethral injury
• In the opinion of the investigator the patient is unsuitable for the study for any other legitimate reason including incarceration, pre-existing medical or psychiatric condition, or interfering medications
• Known previous or concurrent enrollment in a clinical trial that, in the opinion of the investigator, might interfere with the objectives of this clinical trial
• Pregnancy known at the time of presentation

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of physiologic signals as measured by the Accuryn Monitoring System compared to existing gold standard measurements.	During the ICU stay (approximately 2-4 weeks)

Collaborators and Investigators

• Sponsor: Potrero Medical

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2016
• Primary Completion (Actual): January 17, 2018
• Study Completion (Actual): July 20, 2018

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): September 25, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CRD-06-1346

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No