Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients Admitted to Medical Wards
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
研究概览
简要总结
The primary aim of the current study is to assess the effect of continuous wireless vital signs monitoring with generation of real-time alerts compared to blinded monitoring without alerts on the cumulative duration of any severely deviating vital signs in patients admitted to general hospital wards with acute medical conditions. Patients admitted with medical conditions represents a large and heterogenous group occupying a substantial part of the total in-patient capacity in the Danish hospitals today. The hypothesize is that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.
详细描述
Deterioration of patients on general hospital wards often goes unnoticed for prolonged periods of time. This delay can potentially result in severe adverse outcomes such as cardiopulmonary arrest and need for admission to the intensive care unit (ICU). These complications occur despite the fact that, in most cases, measurable changes in physiological vital signs, could identify patients at risk. Moreover, occurrence of complications increase treatment costs considerably underpinning the rationale of early detection of patient deterioration in both human and economic terms.
Monitoring of vital signs outside of ICU or telemetry units usually relies on intermittent manual assessments performed by clinical staff at intervals of up to 12 hours with the "Early Warning Score (EWS)", "Tidlig Opsporing af Kritisk Sygdom (TOKS)" or similar systems. However, significant deterioration may occur in-between these intervals, which may explain the EWS/TOKS score's proven lack of impact on morbidity and mortality in Danish hospitals.
Recent medico-technical advances have allowed for clinical use of small wireless wear-and-forget devices that continuously monitor various indices of cardiopulmonary status, ambulatory activity, temperature etc. Studies suggest that integration of continuous monitoring into automated patient surveillance systems more often detects cardiorespiratory instability and may decrease number of Emergency Response Team activations, ICU transfers, length of hospital stay, morbidity and mortality but further randomized controlled trials (RCTs) are needed to confirm this. Other advantages may be a decrease in the time required for vital signs measurement and recording compared to routine monitoring and overall health care cost savings with return-on-investment estimates ranging from 127%-1739%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
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
- •Inclusion and randomization possible within 12 hours of fulfilling all other inclusion criteria below.
- •Adult patients (≥18 years).
- •At least one (additional) expected overnight stay.
- •High-risk medical admission, defines as EITHER:
- •one or more of the following symptoms or tentative diagnoses: Pneumonia, dyspnea, acute coronary syndrome, new onset heart failure or sepsis WITH two or more of the following deviations in vital signs recorded at one time point within 48 hours of admission:
- •Respiratory rate ≥ 21 min-1 or ≤ 7 min-1
- •Oxygen saturation of arterial hemoglobin ≤ 93 %
- •Pulse rate ≥ 111 min-1 or ≤ 40 min-1
- •Systolic blood pressure ≤ 100 mmHg or > 200 mmHg
- •Temperature > 39 °C or ≤ 35,9 °C
- •Any alteration in mental status
- •Any oxygen supplementation
- •○ Discharged from ICU-stay lasting ≥ 24 hours regardless of cause of ICU-admission.
排除标准
- •Patient expected not to cooperate with study procedures.
- •Allergy to plaster or silicone.
- •Patients admitted for palliative care only (i.e. no active treatment).
- •Planned admission to unit using continuous vital sign monitoring (i.e. an intermediary care/telemetry unit).
- •Patients previously enrolled in the studies WARD-COPD (H-18026653) or WARD-Surgery (H-17033535).
- •Patients previously enrolled in the surgical ward RCT
- •A pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
- •Inability to give informed consent.
结局指标
主要结局
Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
时间窗: 5 days after inclusion or until discharge
● SpO2 \< 85%
次要结局
- Frequency and duration of deviations in vital signs(5 days after inclusion or until discharge)
研究者
Katja Kjær Grønbæk
Principal Investigator
University Hospital Bispebjerg and Frederiksberg