Continuous Monitoring of Vital Signs in Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Expectations & experiences of care givers
研究概览
简要总结
Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is used. Although the MEWS provides relevant data on patients' health status, the interval measurements may not capture early deterioration of vital signs, especially during the night. As a result, unsafe situations may occur such as periods of low oxygen saturation and cardiac arrhythmias, which are known to complicate postoperative course. Besides, this way of measuring vital signs may be stressful for patients and disturbs patients' sleep. New technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of vital signs using wearable devices transmitting relevant data to nurses and clinicians. With this, the investigators think that clinical deterioration may be detected in an early phase and reduce nurse work load and patient distress.
Objective: to investigate the feasibility of wearable devices on the general ward.
Study design: feasibility study.
Study population: adult patients hospitalized on the internal medicine ward and adult postoperative patients on the surgical ward.
Intervention: patients in the intervention groups will be randomized in one of the two groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS measurements take place at usual time points.
Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS measurement (nurse), intervention by nurse after alarm, admission to ICU, complications, side effects of devices, STAI scores, and PCS scores will be documented.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will wear one device for at least three days. Devices can be uncomfortable by being heavy or the patches can start itching. More measurements by nurses can take place when indicated, for example after alarms. The participating patients will fill out the STAI on daily basis and the PCS on the last day of hospitalization. Both questionnaires will take a few minutes to complete. Patients could benefit from early detection of clinical deterioration and early corrective interventions or ICU admissions.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 years or older on the day the informed consent will be signed.
- •Patient is hospitalized on the surgical or internal medicine ward.
- •MEWS measurements are required at least three times a day.
- •Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.
排除标准
- •Frequency of MEWS measurements is less than three times a day.
结局指标
主要结局
Expectations & experiences of care givers
时间窗: 1 year
Interviews with nurses of 15-20 minutes at the end of the study. Estimated amount of 6 nurses
Expectations & experiences of patients
时间窗: 2-3 days after informed consent
Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group
次要结局
- Time between alarm (continuous data) and next regular MEWS measurement (nurse)(during 2-3 days when the patient wears a device)
- Admission to ICU (yes/no)(during 2-3 days when the patient participates in this study)
- Technical failures of devices (artifacts: a period longer than 1 minute the device does not measure vital parameters)(during 2-3 days when the patient wears a device)
- Outcomes of the Pain Catastrophizing Scale (PCS)(On day 2 or 3 when patients participates in the study)
- Outcomes of the State Trait Anxiety Inventory (STAI)(Once a day during the 2-3 days the patient participantes in this study)
- MEWS scores based on continuous data and data measured by nurses(3 times a day, up to three days.)
- Amount of alarms by HealthPatch or ViSi Mobile(during 2-3 days when the patient wears a device)
- Amount of extra MEWS measurements by nurses due to alarms(during 2-3 days when the patient wears a device)
- Duration of ICU hospitalization in days(during 2-3 days when the patient participates in this study)
- Complications caused by disease or surgical procedure(during 2-3 days when the patient participates in this study)
- Adverse events caused by devices(during 2-3 days when the patient wears a device)
- System usability Scale(1 year)