Abdominal Compartment Syndrome, Acute Kidney Injury, Critical Illness, Sepsis, Septic Shock
Conditions
Brief summary
The CAPSS Study is a retrospective and prospective, multi-center, single-arm post-market data collection study with an FDA cleared device. Physiologic data measurements will be collected from enrolled subjects using electronic health records and data streams via the Accuryn Monitoring System. Analysis of these data has the potential to be able to acutely guide resuscitation and monitor trends for emerging critical conditions.
Detailed description
The primary objective of the CAPSS Study is to track and analyze changes in physiologic data streams to identify clinical signatures that may enable earlier diagnosis of, and effective intervention in, critical conditions.
Interventions
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.
Sponsors
Potrero Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Received Accuryn Monitoring System during hospital stay. 2. Diagnosed with or developed one or more of the targeted conditions while connected to the Accuryn Monitoring System.
Exclusion criteria
1\. In the opinion of the investigator, the patient is unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiologic Changes | 30 days | Track and analyze changes in physiologic data streams captured using the Accuryn Monitoring System to identify clinical signatures that may enable earlier diagnosis and effective intervention of critical conditions. Potential examples include AKI, sepsis/septic shock, ACS, and optimization of fluid resuscitation. |
Countries
United States
Outcome results
None listed