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Идёт набор NCT06172491

Automating Delirium Severity in the ICU

— Наблюдательное Intensive Care Unit Delirium Encephalopathy Delirium

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Intensive Care Unit Delirium, Encephalopathy, Delirium. Базовые параметры: от 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Harnessing the Power of Technology to Transform Delirium Severity Measurement in the ICU

Обзор

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.

Подробное описание

Bedside cameras will stay up for at least 72 hours (about 3 days), it may be longer if delirium is being experienced and if the patient and or LAR (Legally Authorized Representative) agree to the cameras' continued recording.

The study team will come and ask the patient questions 4 times daily. We will ask questions about their general, mental, and emotional health, their mood and memory. During these visits, the study team will check the alertness of the patient. Alertness will be checked by voice; if they do not respond, we will tap their shoulder gently. We will ask the patient to do activities like remembering words and saying them back, shaking hands, and drawing an object or clock. The study team will administer assessments 4 times daily. Participants will be asked questions about their general, mental, and emotional health, as well as mood and memory. While performing these sessions, the study team will observe the level of awareness. Awareness will be assessed by voice; if they do not respond, we will have to do a gentle tap on their shoulders. The patient will be asked to perform activities such as: remembering words and repeating them back, handshaking, and drawing an object or clock.

In some cases, if the patient's level of awareness alertness is lowered, we will do observation only perform observation assessments. These assessments do not interfere with clinical care. Participation in this study is voluntary.

The study team will continue to follow the patient until discharged from ICU.

The bedside nurse, patient, or family can cover the cameras with a washcloth if needed for privacy. The faces of family and clinicians and the bathing suit areas of patients are blurred before analysis to protect privacy.

Первичные конечные точки

  • Delirium Severity [Срок оценки: 12-48 months]
  • Acceptability of passive digital marker for delirium severity [Срок оценки: 48 months - 60 months]
  • Usability of passive digital marker for delirium severity [Срок оценки: 48 months - 60 months]

Критерии участия

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.

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Mayo Clinic — Rochester

Публикации

  • Raghu R, Nalaie K, Ayala I, Morales Behaine JJ, Garcia-Mendez JP, Friesen H, Leistikow K, Bhattacharyya A, Jayaraman A, Franco PM, Rabinstein A, Chlan LL, Boustani M, Herasevich V, Lindroth H. Harnessing the Power of Technology to Transform Delirium Severity Measurement in the Intensive Care Unit: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Sep 25;14:e62912. doi: 10.2196/62912. PMID 40998312

Идентификаторы

NCT: NCT06172491 · 22-003098

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗