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Идёт набор NCT05108376

Feasibility and Initial Clinical Impressions of Predictive Monitoring Integrated With the RACE Team

Без фазы С лечением Deterioration, Clinical

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
В протоколе указаны: Visensia Safety Index (VSI).
Кому может быть актуально
Состояния в реестре: Deterioration, Clinical. Базовые параметры: от 18 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Rapid response teams (RRTs) have been adopted by hospitals to provide urgent critical care to hospitalized patients who require quick intervention to prevent further deterioration. Early warning scores (EWS) serve as a method to identify patients requiring RRT assessment by analyzing routinely collected data such as vital signs and laboratory results. The Visensia Safety Index (VSI) is an EWS that uses continuous vital sign monitoring and machine learning to identify the likelihood of deterioration and can be integrated with existing hospital data infrastructure. Initial studies of the VSI have both validated the system and found that patients monitored using VSI had a shorter duration of any instability and fewer episodes of serious and persistent instability. The investigators' recent retrospective analysis at The Ottawa Hospital (TOH) identified that implementation of an EWS could have detected earlier deterioration in over half of the patients identified, potentially preventing subsequent ICU admission, severity of illness, and/or mortality. Thus, this study aims to determine the feasibility and potential impact of implementing a portable continuous monitoring system with a VSI trigger at TOH to identify patients at high risk of deterioration.

Вмешательства

  • Устройство Visensia Safety Index (VSI)
    Enrolled patients will undergo continuous vital sign monitoring, to be used by the Visensia Safety Index (VSI) to identify early deterioration. If early deterioration is identified, the VSI will produce an alert to notify the RACE team.

Первичные конечные точки

  • Evaluate technical feasibility of collecting greater than 80% of continuous data [Срок оценки: Upon study completion, 10 months after study initiation]
  • Evaluate technical feasibility of feeding greater then 80% of continuous data to the predictive tool [Срок оценки: Upon study completion, 10 months after study initiation]
  • Evaluate technical feasibility of updating the predictive tool on a regular basis greater than 80% of the time [Срок оценки: Upon study completion, 10 months after study initiation]
  • Evaluate technical feasibility of reporting greater then 80% of triggers to the RACE team [Срок оценки: Upon study completion, 10 months after study initiation]
  • Evaluate clinical feasibility by assessing MD opinions of the VSI [Срок оценки: Upon study completion, 10 months after study initiation]
  • Evaluate clinical feasibility by assessing RN opinions of the VSI [Срок оценки: Upon study completion, 10 months after study initiation]
  • Evaluate clinical feasibility by assessing RT opinions of the VSI [Срок оценки: Upon study completion, 10 months after study initiation]
  • Evaluate financial feasibility of implementing the VSI system [Срок оценки: Upon study completion, 10 months after study initiation]
Вторичные конечные точки (2)
  • Evaluate potential clinical impact of the VSI [Срок оценки: Upon study completion, 10 months after study initiation]
  • Evaluate potential financial impact of the VSI [Срок оценки: Upon study completion, 10 months after study initiation]

Критерии участия

Критерии включения

Adult patient (greater than or equal to 18 years of age) designated for the most aggressive levels of potential intervention (Category 1 status - Full Care and Category 2 status - Full Care except CPR) who belong to one of the following groups:

  • Patients who have undergone high risk elective surgery (Whipple procedures, high risk vascular surgery, high risk general surgery, among others)
  • Malignant haematology or oncology patients at high risk for deterioration
  • Patients with infection admitted from the Emergency Department (ED) to the ward
  • Other high-risk patients determined at the discretion of the clinical team

Критерии исключения

  • Patients admitted to a unit with higher level monitoring (Neurological Acute Assessment Unit, Acute Monitoring Area, Trauma Step-Down, Intensive Care Unit)
  • Patients with Category III (Full Care except Respiratory or Hemodynamic Life Support, or CPR) or IV status (Comfort Care)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Канада · 1 центр
  • The Ottawa Hospital — Ottawa

Публикации

  • Tran A, Ramchandani R, Brehaut J, Hudek N, Haines J, Watpool I, Porteous R, Kusevic D, Bucciero K, Kyeremanteng K, Hartwick M, Thavorn K, Hooper J, Kubelik D, Herry C, Scales N, Hryciw B, Abou-Khalil J, Perry J, Bredeson C, Seely A. Assessing Clinical Impressions of Early Warning Score Integration With the Rapid Response Team: Protocol for a Prospective Cohort Study. JMIR Res Protoc. 2025 Jul 31;1 PMID 40742731

Идентификаторы

NCT: NCT05108376 · 3199

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗