Continuous Vital Sign Monitoring Versus Routine Spot-checks in Patients After Non-cardiac Surgery
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: Unblinded continuous vital sign monitoring, Blinded continuous vital sign monitoring.
- Кому может быть актуально
- Состояния в реестре: Vital Sign Monitoring, Post Operative Complications, Non-cardiac Surgery, RCT. Базовые параметры: от 45 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
- Германия
- 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
The Effect of Continuous Monitoring Versus Routine Spot-checks on Altered Vital Signs in Patients Recovering From Non-cardiac Surgery on Normal Wards: the "COME ON, NOW!" Trial
Обзор
The "COME ON, NOW!" trial is a randomized, single-center trial in patients recovering from non-cardiac surgery on normal wards investigating whether continuous vital sign monitoring - compared to routine spot-checks by nurses - reduces the total duration of abnormal vital signs per hour during the first 48 hours after admission to the normal ward.
Подробное описание
"Surgery went well, and everything is fine. Your relative is still in the operating room, but you can visit her/him this afternoon on the normal ward." Each day, thousands of patient families receive relieving calls like this. A call better reflecting clinical reality would be: "Surgery went well, and everything is fine so far - but the most dangerous time is still ahead. The postoperative period poses a much higher risk for patients than surgery itself." Indeed, rates of major postoperative complications and death remain frighteningly high. If the month after surgery were considered a disease, it would be the third leading cause of death worldwide. Most major complications and deaths occur during the initial hospitalization, under direct medical care.
Postoperative deterioration is usually preceded by changes in vital signs minutes to hours earlier. However, these alterations are frequently missed because vital signs on normal wards are typically assessed only every 4-8 hours. Continuous monitoring may allow earlier detection of instability and enable timely interventions to prevent or mitigate serious complications.
The investgators therefore propose a single-center randomized trial in adults recovering from major non-cardiac surgery on normal wards to compare continuous postoperative vital sign monitoring with routine intermittent spot-checks. Patients will be randomized to blinded or unblinded continuous monitoring using a wearable, wireless sensor system (Radius VSM, Masimo, Irvine, CA). In the unblinded group, clinicians will receive real-time alerts.
The primary outcome will be the cumulative duration of vital sign abnormalities during the first 48 hours on the ward. Secondary outcomes will include clinical interventions triggered by these abnormalities. Exploratorily, the investigators will assess a composite of serious in-hospital complications.
Our long-term goal is to reduce postoperative morbidity and mortality by enabling earlier recognition of clinical deterioration and timely intervention on general wards.
Вмешательства
- Устройство Unblinded continuous vital sign monitoring
Continuous ward monitoring with vital signs available to investigators. Oxygen saturation, blood pressure (intermittent in intervals of 60 minutes), heart rate, and respiratory rate will be continuously measured and streamed to the investigators (specifically, to a central monitor). The investigators will alert nurses or physicians when SpO2 is \<85% for ≥2 minutes, respiratory rate is \<7/min or \>30/min for ≥2 minutes, MAP is \<60 mmHg, or heart rate is \<45 bpm or \>130 bpm for ≥2 minutes, or - Устройство Blinded continuous vital sign monitoring
Continuous ward monitoring with vital signs recorded but not available to patients, clinicians, or investigators.
Первичные конечные точки
- Total duration of abnormal vital signs [Срок оценки: 48 hours after admission to the normal ward]
Вторичные конечные точки (12)
- Individual components of the composite primary endpoint [Срок оценки: 48 hours after admission to the normal ward]
- Individual components of the composite primary endpoint [Срок оценки: 48 hours after admission to the normal ward]
- Individual components of the composite primary endpoint [Срок оценки: 48 hours after admission to the normal ward]
- Individual components of the composite primary endpoint [Срок оценки: 48 hours after admission to the normal ward]
- Individual components of the composite primary endpoint [Срок оценки: 48 hours after admission to the normal ward]
- Individual components of the composite primary endpoint [Срок оценки: 48 hours after admission to the normal ward]
- Quantitative metrics of peripheral oxygen saturation [Срок оценки: 48 hours after admission to the normal ward]
- Quantitative metrics of peripheral oxygen saturation [Срок оценки: 48 hours after admission to the normal ward]
- Quantitative metrics of peripheral oxygen saturation [Срок оценки: 48 hours after admission to the normal ward]
- Quantitative metrics of peripheral oxygen saturation [Срок оценки: 48 hours after admission to the normal ward]
- Quantitative metrics of peripheral oxygen saturation [Срок оценки: 48 hours after admission to the normal ward]
- Quantitative metrics of mean arterial pressure [Срок оценки: 48 hours after admission to the normal ward]
Критерии участия
Критерии включения
Consenting patients ≥45 years scheduled for elective non-cardiac (abdominal and thoracic) surgery with planned postoperative admission to a normal ward after an overnight stay in an advanced post-anesthesia care unit.
Критерии исключения
- Emergency surgery
- Pregnancy
- Impossibility to perform continuous monitoring with the Radius VSM sensor (Masimo, Irvine, CA)
- Atrial fibrillation
- Patients designated Do Not Resuscitate, or are receiving end-of-life care
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Германия · 1 центр
- University Medical Center Hamburg-Eppendorf — Hamburg
Идентификаторы
NCT: NCT07385092 · 2023-101178-BO-ff