Early Delirium Prediction Via Serial EEG Trajectories and Machine Learning
NCT07536854
Brain Dysfunction, Confusion
Suwon, Kyonggi-do, South Korea
View Trial DetailsNCT Number: NCT04551508
Observational study comparing three different methods of delirium detection in critically ill patients.
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Notify Me18 year and older
All sexes
Observational
Odense Universitetshospital, Odense, C, Denmark
The DELIS-3 study aims to compare three different approaches to detection of ICU (intensive care unit) delirium in critically ill patients. The CAM-ICU (Confusion Assessment Method for the ICU) and the ICDSC (Intensive Care Delirium Screening Checklist) have both been developed in the early 1990. The CAM-ICU is either positive or negative, whereas the ICDSC is a score between 0-8. A score above 3 is delirium positive. Neither scale has been validated as severity scales. The novel CAM-ICU-7 is developed from the original CAM-ICU and has been validated as a severity scale.
Detection of delirium in critically ill patients is highly necessary as delirium can be very painful to the patient. Moreover, certain subtypes of delirium is associated with increased mortality and poorer cognitive outcome when patients are followed up on long term.
Therefore, delirium screening of all patients is standard care in most intensive care units.
However, there is also a need to assess severity of delirium. The recently published CAM-ICU-7 has now been translated to Danish and this study will explore its performance compared to the CAM-ICU and the ICDSC.
In 17 Danish ICU's 10 nurses will be trained in using all three instruments. Each nurse will subsequently screen 10 patients each with all three instruments as part of their normal practice. The sequence of the instruments will be randomized to avoid that one instrument is favored by always being used first, second or last.
For each patient the following data will be collected: sex, age, reason for hospitalization (medical, neurological, surgical/ acute, planned), ventilator treatment, ability to verbalize, RASS score (sedation and agitation score) severity of disease (SMS score) and time of admission.
After all screenings has been collected, nurses will fill in a questionnaire on their perceptions of each scales' ability to reliably detect delirium, userfriendliness and how time consuming each scale were to use.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 1
Clinical test for detecting delirium bedside, can be used by non-psychiatrists. CAM-ICU can be either positive (indicating delirium) or negative.
Time frame: Day 1
Clinical test for detecting delirium bedside, can be used by non-psychiatrists. CAM-ICU-7 can yield a score of 0-7 points, higher values indicative of worse delirium.
Time frame: Day 1
Clinical test for detecting delirium bedside, can be used by non-psychiatrists. ICDSC can yield a score of 0-8 points, higher values indicative of worse delirium.
Hospitalsenheden Vest
Other
Delirium Screening 3 Methods Study (DELIS-3). Agreement Between CAM-ICU, CAM-ICU-7 and ICDSC in a Danish Population of ICU Patients and Nurses' Perception of the Clinical Relevance of Delirium Screening
Acronym: DELIS-3
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