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Идёт набор NCT06289699

Alert Frequency, Nurse, and Patient Satisfaction With a wCVSM Software Across Health Care Systems and Cultures

— Наблюдательное User Experience Postoperative Complications Acute Medical Conditions

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: User Experience, Postoperative Complications, Acute Medical Conditions. 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
США, Германия, Нидерланды, Норвегия, Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Alert Frequency, Nurse, and Patient Satisfaction With a Continuous Wireless Vital Sign Monitoring Software Across Health Care Systems and Cultures

Обзор

The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction.

Подробное описание

The participants will be monitored for 4 days postoperatively or for 4 days after acute admission and until discharge.

Monitoring devices used in this study will be validated FDA or/and CE approved devices used within their original purpose. Centers can choose to use Sotera Visimobile or Isansys Lifeguard with accompanying sensors. These devices will be used together with the CE approved WARD web and mobile application.

Study sites include: St. Olav Hospital Trondheim, Royal Liverpool University Hospital, University Medical Centre Hamburg-Eppendorf,University Medical Centre Groningen, The Netherlands and the Cleveland Clinic.

Первичные конечные точки

  • Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data [Срок оценки: during monitoring period, on average 3 months]
Вторичные конечные точки (12)
  • Technical feasibility [Срок оценки: during monitoring period, on average 3 months]
  • Alert relay to smartphones [Срок оценки: during monitoring period, on average 3 months]
  • Response to alerts [Срок оценки: during monitoring period, on average 3 months]
  • Patients experiences from being monitored with wCSVM. [Срок оценки: during monitoring period, on average 3 months]
  • Relevance of alarms [Срок оценки: during monitoring period, on average 3 months]
  • Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day [Срок оценки: during monitoring period, on average 3 months]
  • Frequency of delivered alarms on respiration rate (RR) pr patient pr day [Срок оценки: during monitoring period, on average 3 months]
  • Frequency of delivered alarms on heart rate (HR) pr patient pr day [Срок оценки: during monitoring period, on average 3 months]
  • Frequency of delivered alarms on blod pressure (BP) pr patient pr day [Срок оценки: during monitoring period, on average 3 months]
  • Overall score of user satisfaction from use of WARD24/7 app [Срок оценки: during monitoring period, on average 3 months]
  • Subscale MAUQ scores [Срок оценки: during monitoring period, on average 3 months]
  • Monitoring practices prior to the wCVSM [Срок оценки: Baseline, on average 3 months]

Критерии участия

Критерии включения

  • Adults (≥18 years)
  • Expected stay in the hospital ≥2 days
  • Admitted for surgery with expected duration of surgery >2 hours or admitted for acute medical condition with at least one of the following vital sign deviations within 24 hours of acute admission, recorded by the staff
  • RR > 21 breaths pr minute
  • RR < 11 breaths pr minute
  • Pulse (P) > 91 beats pr minute
  • Pulse (P) < 50 beats pr minute
  • SpO2 < 94 % without oxygen supplementation
  • Systolic BP < 110 mmHg
  • Systolic BP > 220 mmHg

Критерии исключения

  • Participant expected not to cooperate with study procedures.
  • Allergy to plaster or silicone.
  • Pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
  • Inability to give informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

США · 1 центр
  • The Cleveland Clinic Foundation, General Anesthesiology — Cleveland
Германия · 1 центр
  • Universitätsklinikum Hamburg-Eppendorf (UKE), Zentrum für Anästhesiologie und Intensivmedi — Hamburg
Нидерланды · 1 центр
  • University Medical Center Groningen, Department of Anesthesiology — Groningen
Норвегия · 1 центр
  • St. Olavs Hospital HF, Klinikk for anestesi og intensivmedisin — Trondheim
Великобритания · 1 центр
  • Liverpool University Hospitals NHS Foundation Trust — Liverpool

Идентификаторы

NCT: NCT06289699 · WARD-CSS international 1251

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗