Continuous Monitoring of Vital Parameters for Early Detection of Clinical Deterioration in Hospitalized Patients - a Part of the Wireless Assessment of Respiratory and Circulatory Distress (WARD) Project
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Serious desaturation
研究概览
简要总结
For patients admitted to the medical ward, it is often difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. The WARD project aims to determine the correlation between cardiopulmonary micro events and clinical adverse events during the first four days after hospital admission.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults >18 years
- •Acute hospitalization or discharge from Intensive Care Unit (ICU) after an admission of at least 24 hours.
- •Early Warning Score (EWS) ≥4 at least once from admission and until inclusion
- •One of the following tentative diagnoses as the primary reason for admission: Pneumonia, Dyspnea, Acute myocardial infarction, heartfailure or sepsis
- •Inclusion conversation possible within 12 hours of admission or discharge from ICU
排除标准
- •Patients that cannot cooperate
- •Patients that cannot give informed consent
- •Patients with EWS≥4 that is not of presumed physical origin
- •Patients with allergies to plaster or silicone
- •Patients with pacemaker or ICD
- •Patients with treatment limitations (no resuscitation or no admission to ICU)
- •Patients with expected discharge within 24 hours
- •Patients that have been included in the WARD-COPD study (H-18026653)
结局指标
主要结局
Serious desaturation
时间窗: more than 10 minutes, within the first four days of acute admission
SpO2 \<85% in 10 consecutive minutes
次要结局
- tachycardia(one minute within the first four days of admission)
- bradycardia(one minute within the first four days of admission)
- tachypnea(one minute within the first four days of admission)
- desaturation(more than 60 minutes, within the first four days of acute admission)
- bradypnea(one minute within the first four days of admission)
- hypotension(one measurement within the first four days of admission)
- hypertension(one measurement wihtin the first four days of admission)
研究者
Katja Kjær Grønbæk
MD, PhD-student
University Hospital Bispebjerg and Frederiksberg