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

NCT02602782 | Completed

• 1 other identifier: CRD-06-1346
• Study Type: observational
• Target: 76
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Critical Care, Intensive Care

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Significantly injured trauma ICU patients receiving a Foley catheter and transfusion

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Potrero Medical: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 11, 2015
• Study Start: February 4, 2016
• Primary Completion: January 17, 2018
• Study Completion: July 20, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09