RecruitingNCT04669548

Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry

Physiologic Signals and Signatures With the Accuryn Monitoring System - A Retrospective and Prospective Analysis (The Accuryn Registry)

Sponsor

Potrero Medical

Enrollment

2,500 participants

Start Date

Dec 21, 2020

Study Type

OBSERVATIONAL

Conditions

Acute Kidney Injury Intraabdominal Hypertension Abdominal Compartment Syndrome Cardiovascular Surgery

Summary

The Accuryn Registry Study is an open-ended, global, multi-center, retrospective and prospective, single-arm data collection study with an FDA cleared device. The target population are cardiovascular surgery patients. Physiologic data measurements will be collected from enrolled subjects using electronic medical records and data streams via the Accuryn Monitoring System.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Signed or Verbal Informed Consent as required by IRB (if applicable).
Adult (age ≥ 18).
Monitored on the Accuryn® Monitoring System during their procedure and ICU stay (for retrospective enrollment).
Patient is undergoing cardiac surgical intervention(s).

Exclusion Criteria2

Known history of advanced chronic kidney disease defined by an estimated glomerular filtration rate (eGFR) \<20 mL/min/1.73m2 within 30 days prior to procedure.
The patient is unsuitable for the study, in the opinion of the investigator. This may include vulnerable patient populations such as pregnant women, prisoners ,or those detained in a penal institution.

Interventions

DEVICEAccuryn Monitoring System

The Accuryn Monitoring System is a novel Foley catheter and monitoring device capable of detecting physiologic changes in vital signs via sensors within the catheter system. These data are captured non-invasively, continuously, and at a high frequency.