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Идёт набор NCT07690267

Continuous Vital Sign Monitoring in a Surgical Ward

Наблюдательное Patient Monitoring Wearable Devices Telemonitoring Patient Safety

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: Continuous Vital Sign Monitoring (CVSM).
Кому может быть актуально
Состояния в реестре: Patient Monitoring, Wearable Devices, Telemonitoring, Patient Safety. 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
Норвегия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Continuous Vital Sign Monitoring in a Norwegian Hospital Surgical Ward: A Multi-Method Study of Patient Outcomes, Patient Safety Culture, and Nursing Staff Experiences

Обзор

Unsafe patient care remains a major contributor to global morbidity and mortality. In surgical wards, postoperative patients are typically monitored intermittently using the National Early Warning Score (NEWS-2), leaving periods during which clinical deterioration may go undetected. Continuous vital sign monitoring (CVSM) using wearable sensors offers the potential for earlier identification of deterioration compared with intermittent assessments. CVSM was introduced in a hospital ward as part of a hospital-initiated pilot implementation and is used alongside standard monitoring with NEWS-2. The purpose of the study is to evaluate this implementation. This observational study uses a pragmatic, quasi-experimental, multi-method, longitudinal design. The overall aims of the study are to evaluate the impact of CVSM implementation on patient outcomes, to explore healthcare professionals' perceptions of patient safety culture, turnover intention and pleasure of work, and to describe their experiences with implementation.

Подробное описание

Unsafe care is a major contributor to global morbidity and mortality. In surgical wards, postoperative patients are typically monitored intermittently using the National Early Warning Score (NEWS-2), which may leave periods during which changes in vital signs go undetected, potentially increasing the risk of clinical deterioration. Continuous vital sign monitoring (CVSM) using wearable sensors may enable earlier detection of deterioration compared with intermittent monitoring.

This study evaluates the implementation of CVSM using 16 wearable sensors in a 29-bed gastro-surgical ward beginning in September 2025. CVSM is based on wearable sensors that continuously monitor patients' respiratory rate, heart rate, and oxygen saturation. The system transfers data to the electronic health record, and alerts are generated when predefined thresholds are exceeded and delivered to nursing staff via smartphones and workstation monitors. CVSM is implemented in addition to usual care, including intermittent NEWS-2 monitoring, in accordance with hospital protocol.

The intervention was implemented as part of a hospital-initiated pilot programme that was supported by hospital management and aimed to evaluate the feasibility and potential effects of broader CVSM adoption. The intervention ward was selected by the hospital for pragmatic reasons, based on managers' agreement to implement CVSM. Implementation was overseen by a hospital-appointed project manager. Members of the research team participated in implementation meetings and provided input on potential implementation strategies. However, responsibility for implementation decisions remained with hospital management and the clinical departments, and implementation was primarily guided by clinical priorities and operational constraints within the hospital. The primary role of the research team was to support and conduct the empirical evaluation of the intervention and its implementation.

It is hypothesised that CVSM may enable earlier detection of patient deterioration compared with intermittent monitoring alone and thereby influence patient outcomes. It is also hypothesised that CVSM may influence healthcare professionals' perceptions of patient safety culture, turnover intention, and work-related well-being. The study will further generate knowledge about healthcare professionals' experiences with the implementation.

While data collection for the studies on patient safety culture and nurses' experiences with implementation has started, the patient outcome study is currently awaiting a decision from the Norwegian Directorate of Health. Data collection for this study has not yet commenced. The studies on patient safety culture and nurses' experiences with implementation have been preregistered in the Open Science Framework (OSF).

Вмешательства

  • Другое Continuous Vital Sign Monitoring (CVSM)
    The intervention consists of continuous vital sign monitoring (CVSM) using wearable sensors applied to patients. A total of 16 sensors are implemented in a 29-bed gastro-surgical ward. The system continuously records patients' vital signs and transfers data to the electronic health record. Alerts are generated when predefined thresholds are exceeded and are delivered to nursing staff via smartphones and workstation monitors. The intervention is implemented in addition to usual practice with inte

Первичные конечные точки

  • NEWS-2 Associated with RRT Activation [Срок оценки: Up to 12 months after implementation]
  • Patient Safety Culture (N-HSOPSC 2.0) [Срок оценки: Baseline, 5 months, and 12 months after implementation]
  • Nursing Staff Experiences with CVSM [Срок оценки: Approximately 6 months after implementation]
Вторичные конечные точки (5)
  • Rapid Response Team (RRT) Activation [Срок оценки: Up to 12 months after implementation]
  • Unplanned Transfers to Higher Level of Care [Срок оценки: Up to 12 months after implementation]
  • NEWS-2 at Time of Clinical Deterioration [Срок оценки: Up to 12 months after implementation]
  • Hospital Length of Stay [Срок оценки: Up to 12 months after implementation]
  • Pleasure of Work and Turnover Intention [Срок оценки: Baseline, 5 months, and 12 months after implementation]

Критерии участия

Критерии включения

  • Patients aged 18 years or older admitted to the gastro-surgical ward.
  • Healthcare professionals aged 18 years or older employed in the participating wards for survey participation.
  • Nursing staff with at least 6 months of work experience and experience using CVSM for participation in qualitative focus group interviews.

Критерии исключения

  • Patients with delirium.
  • Patients with cognitive impairment interfering with sensor use.
  • Patients who decline participation.
  • Patients with allergy to electrode adhesives.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Норвегия · 1 центр
  • Akershus University Hospital HF — Lørenskog

Идентификаторы

NCT: NCT07690267 · CVSM-2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗