Automating Delirium Severity in the ICU

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06172491
Status
Recruiting
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Conditions

  • Delirium
  • Encephalopathy
  • Intensive Care Unit Delirium

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The goal of this observational study is to develop a passive digital marker (PDM) for delirium severity and examine its performance in comparison to validated delirium severity tools in ICU patients \>50 years of age. The main questions it aims to answer are: * Is the trained convolutional neural network able to reliably measure delirium severity. * Is the Passive Digital Marker able to accurately measure delirium severity * Is the Passive Digital Marker acceptable and usable by frontline ICU nurse clinicians, patients, and their identified proxies (i.e., caregivers). Participants will: * Study participation involves a video camera recording you 24 hours per day while you are a patient in the Intensive Care Unit (ICU). * Study staff will visit you 4 times each day you are in the ICU. You will be asked questions each time they visit to train the digital marker and see differences between assessments and camera data.

Key Dates

Start date
Jan 15, 2023
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: No Delirium Severity
    Patients who did not experience a level of delirium severity (subsyndromal, mild, moderate, severe)
  • Arm: Delirium Severity
    Patients who did experience a level of delirium severity (subsyndromal, mild, moderate, severe)

Primary Outcome Measure

Delirium Severity [ Time Frame: 12-48 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Hannah Friesen
[email protected]
507-284-2197
Heidi Lindroth, Ph.D., R.N. (PRINCIPAL_INVESTIGATOR)
Anirban Bhattacharyya, M.D.,M.S (SUB_INVESTIGATOR)
Arun Jayaraman, M.D,Ph.D (SUB_INVESTIGATOR)
Linda Chlan, Ph.D (SUB_INVESTIGATOR)
Vitaly Herasevich, M.D.,Ph.D (SUB_INVESTIGATOR)
Alejandro Rabinstein, M.D. (SUB_INVESTIGATOR)
Malaz Boustani, M.D. M.P.H. (SUB_INVESTIGATOR)

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