NCT06172491 Automating Delirium Severity in the ICU
| NCT ID | NCT06172491 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Intensive Care Unit Delirium |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-01-15 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2023-01-15 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: • Age \>50; * Estimated length of stay \>24 hours in ICU; and * Are not admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal. Exclusion Criteria: * Admitted for acute alcohol intoxication, drug (prescribed or illicit) overdose or withdrawal. * Admitted for acute neuronal injury * Unable to communicate with research team due to sensory deficits (aphasic, blind, deaf) or language (does not speak English)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06172491 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Intensive Care Unit Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06172491 currently recruiting?
Yes, NCT06172491 is actively recruiting participants. Contact the research team at lindroth.heidi@mayo.edu for enrollment information.
Where is the NCT06172491 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06172491 clinical trial?
NCT06172491 is sponsored by Mayo Clinic. The trial plans to enroll 400 participants.