Alert Frequency, Nurse, and Patient Satisfaction With a Continuous Wireless Vital Sign Monitoring Software Across Health Care Systems and Cultures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data
研究概览
简要总结
The goal of this prospective, international multi-centre pilot study is to assess the functionality and user experience of a new vital sign monitoring system in 20 patients and 20 nurses in the general ward at each centre. The patients will be monitored with a wireless, continuous vital sign monitoring systems and answer a questionnaire afterwards. They will in addition have vital signs monitored as per standard practice. The nurses will answer a questionnaire after having had the responsibility for a monitored patient for a full shift. The main aims are: To determine the frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data, to explore current practices of in-hospital monitoring by semi-structured interviews to map differences across systems and to test nurse and patient satisfaction.
详细描述
The participants will be monitored for 4 days postoperatively or for 4 days after acute admission and until discharge.
Monitoring devices used in this study will be validated FDA or/and CE approved devices used within their original purpose. Centers can choose to use Sotera Visimobile or Isansys Lifeguard with accompanying sensors. These devices will be used together with the CE approved WARD web and mobile application.
Study sites include: St. Olav Hospital Trondheim, Royal Liverpool University Hospital, University Medical Centre Hamburg-Eppendorf,University Medical Centre Groningen, The Netherlands and the Cleveland Clinic.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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)
- •Expected stay in the hospital ≥2 days
- •Admitted for surgery with expected duration of surgery >2 hours or admitted for acute medical condition with at least one of the following vital sign deviations within 24 hours of acute admission, recorded by the staff
- •RR > 21 breaths pr minute
- •RR < 11 breaths pr minute
- •Pulse (P) > 91 beats pr minute
- •Pulse (P) < 50 beats pr minute
- •SpO2 < 94 % without oxygen supplementation
- •Systolic BP < 110 mmHg
- •Systolic BP > 220 mmHg
排除标准
- •Participant expected not to cooperate with study procedures.
- •Allergy to plaster or silicone.
- •Pacemaker or Implantable Cardioverter Defibrillator (ICD) device.
- •Inability to give informed consent.
结局指标
主要结局
Frequency of alerts activated in the app in relation to the alerts that should be activated based on measured data
时间窗: during monitoring period, on average 3 months
次要结局
- Frequency of delivered alarms on respiration rate (RR) pr patient pr day(during monitoring period, on average 3 months)
- Frequency of delivered alarms on heart rate (HR) pr patient pr day(during monitoring period, on average 3 months)
- Overall score of user satisfaction from use of WARD24/7 app(during monitoring period, on average 3 months)
- Subscale MAUQ scores(during monitoring period, on average 3 months)
- Technical feasibility(during monitoring period, on average 3 months)
- Response to alerts(during monitoring period, on average 3 months)
- Patients experiences from being monitored with wCSVM.(during monitoring period, on average 3 months)
- Frequency of delivered alarms on oxygen saturation (SpO2) pr patient pr day(during monitoring period, on average 3 months)
- Alert relay to smartphones(during monitoring period, on average 3 months)
- Relevance of alarms(during monitoring period, on average 3 months)
- Frequency of delivered alarms on blod pressure (BP) pr patient pr day(during monitoring period, on average 3 months)
- Monitoring practices prior to the wCVSM(Baseline, on average 3 months)
研究者
Christian S. Meyhoff
Professor, PhD
University Hospital Bispebjerg and Frederiksberg