Harnessing the Power of Technology to Transform Delirium Severity Measurement in the Intensive Care Unit: Protocol for a Prospective Cohort Study.
Roshini Raghu, Keivan Nalaie, Ivan Ayala...
https://pubmed.ncbi.nlm.nih.gov/40998312Actively Recruiting
Led by Mayo Clinic · Updated on 2026-04-08
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are studying delirium severity in patients over 50 years old who are admitted to the Intensive Care Unit (ICU). This observational study aims to develop a passive digital marker (PDM) using video recordings and a trained convolutional neural network to measure delirium severity. The study also evaluates how well this digital marker compares to traditional delirium severity tools and examines its acceptance and usability by ICU nurses, patients, and caregivers. During the study, bedside cameras will record patients continuously for at least 72 hours while in the ICU, with possible extension if delirium persists and consent is given. Study staff will visit patients four times daily to ask questions about their mental, emotional health, mood, memory, and to assess alertness through voice and gentle physical prompts. Patients will also be asked to perform simple activities such as remembering and repeating words, shaking hands, and drawing objects or clocks. If a patient's alertness is lowered, observational assessments will be performed without interfering with clinical care. Participants will be monitored until discharge from the ICU. Privacy is protected by allowing coverage of cameras and blurring faces of family, clinicians, and sensitive areas before analysis. Researchers will measure delirium severity, as well as the acceptability and usability of the passive digital marker over periods ranging from 12 to 60 months. Participation is voluntary and involves detailed assessments and continuous video monitoring during ICU stay.
CONDITIONS
Automating Delirium Severity in the ICU
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 3 days, continuing until ICU discharge if delirium persists
Participants are observed with bedside cameras for at least 72 hours, with recordings possibly continuing longer if delirium is experienced and agreed upon. The study team will visit participants 4 times daily to assess their mental and emotional health, mood, memory, and alertness through questions and activities like handshaking and drawing. Observation assessments are performed without interfering with clinical care.
4 visits daily until ICU discharge
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
H
Heidi Lindroth, PH.D. R.N.
H
Hannah Friesen
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Roshini Raghu, Keivan Nalaie, Ivan Ayala...
https://pubmed.ncbi.nlm.nih.gov/40998312