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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02602782

Acronym

PRESCIENT

Enrollment

Registered

2015-11-11

Start date

2016-02-04

Completion date

2018-07-20

Last updated

2018-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care, Intensive Care

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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)

Outcome results