Physiologic Signals and Signatures With the Accuryn™ Monitoring System in Intensive Care Patients (NCT02602782)

Study 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 studied

Critical Care, Intensive Care

In context

Lead sponsor

Potrero Medical is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Significantly injured trauma ICU patients receiving a Foley catheter and transfusion

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

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 design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 76 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02602782
Lead sponsor: Potrero Medical
Responsible party: Sponsor
First posted: Nov 11, 2015
Start date: Feb 4, 2016
Primary completion: Jan 17, 2018
Completion: Jul 20, 2018
Last update: Sep 25, 2018

Oversight

FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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