The Virtual High Dependency Unit (vHDU) Project Phase 5: Impact of an Ambulatory Monitoring System on Deterioration Detection and Clinical Outcomes. A Feasibility Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Time from first period of unexpected physiological instability to set of observations
研究概览
简要总结
Sometimes in hospital, it is not noticed that patients are becoming unwell quickly enough. This may mean that they are less likely to survive than if the worsening of their illness had been picked up sooner. One reason for this may be that hospital staff are unable to check patients' vital signs (such as breathing rate, heart rate and level of oxygen in their blood) frequently enough to help them decide if a patient is becoming more unwell. Currently, for nurses to watch these vital signs closely, patients are either attached to a static machine by the patient's bedside using wires, or staff visit the patient every few hours to measure these vital signs using a portable wired machine. It is now possible to closely monitor patients using small devices which attach to the wrist, finger or chest. These devices allow nursing staff to continually watch vital signs data from these patients when they are away from their bedside. These machines are also wireless and portable, so they do not stop patients moving around, which is important for recovery, and are comfortable to wear. In past years, the investigators have tested these devices and developed a system to allow the clinical staff to see the continuous vital signs. In this final stage of the project, the investigators will test this system (with the selected devices) on patients in hospital. The investigators will start by doing a small trial on one surgical ward, and asking for staff and patient feedback of how the system worked, how useful it was, and how easy to use. If the feedback from this first small trial is positive, the investigators will conduct a future trial in several hospitals, to test how useful the system is in improving patient recovery.
详细描述
The primary objective of this study is to assess the impact of ambulatory monitoring systems (AMS) integration (with active clinical alerts) versus standard care in deterioration detection.
Secondary objectives include other deterioration detection and clinical outcomes, trial progression outcomes, staff impact and alerting system performance, overall system reliability and patient experience.
This study is a superiority feasibility randomised controlled trial with two-arm parallel groups and 1:1 allocation ratio to compare the use of an ambulatory monitoring system with standard care in hospitalised patients. This feasibility trial will be conducted not only to assess the impact of AMS on early deterioration detection and other clinical outcomes but also to explore recruitment rate, calculate required sample size, number of sites and recruitment period for a full definitive RCT.
Participants will be recruited in one or more surgical wards inside Oxford University Hospitals NHS Foundation Trust (to be decided during feasibility trial, dependant on recruitment rate). Patients will be screened, recruited and participate in this study throughout their hospital stay, no follow-up visits will be required.
The intervention consists in the use of AMS that also includes an alerting system. Participants will wear one pulse oximeter (WristOx2 3150 OEM BLE, shorted to "Nonin", hereafter) measuring pulse rate (PR) and oxygen saturation (SpO2), one chest patch (VitalPatch) that will continuously measure their heart rate (HR), respiratory rate (RR), temperature,; and one A&D UA-1200 BLE Blood Pressure device, intermittently measuring systolic and diastolic blood pressure, and pulse rate. Clinical staff will be able to access and interact with real-time vital signs through a dashboard style display and will be alerted via a hand-held device, and/or dashboard, according to the patient's EWS score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient stable for at least 6 hours with at least one of the following:
- •NEWS2 <= 2 and (in some exceptional NEWS >2 confirmed with clinical staff, eg. patients with comorbidities).
- •Frequency of observations of >4 hours at the time of randomisation.
- •Participant is willing and able to give informed consent for participation in the trial.
- •Male or Female, aged 18 years or above.
- •Any patient admitted to the participating surgical unit (including post-ICU patients) who are not currently monitored with standard continuous monitoring
排除标准
- •The participant may not enter the trial if ANY of the following apply:
- •Intra-cardiac device
- •Monitored for less than 24 hours
研究组 & 干预措施
AMS group
Patients randomised to the intervention group will receive the AMS; this will be connected to the dashboard and the alerting system. Clinical staff will have access to the dashboard and alerted accordingly for the assigned patients.
干预措施: Ambulatory monitoring system (Device)
AMS group
Patients randomised to the intervention group will receive the AMS; this will be connected to the dashboard and the alerting system. Clinical staff will have access to the dashboard and alerted accordingly for the assigned patients.
干预措施: Active alerting system (Device)
Standard Care group
Patients in the control group will also receive the AMS however this will not be connected to the ward dashboard and clinical staff will not be able to access these patient's continuous vital signs:
- Patient will not appear on the ward dashboard
- No alerting system will be given to staff
干预措施: Ambulatory monitoring system (Device)
结局指标
主要结局
Time from first period of unexpected physiological instability to set of observations
时间窗: Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.
To assess the impact of AMS integration (with active clinical alerts) versus standard care in deterioration detection
次要结局
- Frequency of periods of physiological instability.(Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.)
- ICU admission rate(Throughout patient ward and hospital length of stay, expected to be anywhere from 2 to 30 days.)
- Adverse event/complication rate(Throughout patient ward and hospital length of stay, expected to be anywhere from 2 to 30 days.)
- Cardiac arrest team call frequency(Throughout patient ward and hospital length of stay, expected to be anywhere from 2 to 30 days.)
- Time difference between deterioration detection by nurse and AMS (control group only).(Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.)
- Frequency of unscheduled interventions(Throughout patient monitoring period, expected to be anywhere from 2 to 14 days.)