PJ-013483 FLAGSHIP Transitional Care Study 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity
研究概览
简要总结
In this study patients with elective surgery will wear two devices (HealthDot and Elan) after surgery in hospital and after discharge at home for up to 2 weeks (HealthDot) or 3 weeks (Elan). The HealthDot will measure heart rate, posture, activity and respiratory rate which are stored on the device as well as sent to Philips. The Elan device will measure PPG and accelerometer data which is transferred to Philips. The data collected will be used for algorithm development. Data will be analysed retrospectively and compared to readmission and adverse events to see if the events could have been predicted due to the collected data by the devices. No clinical decisions will be based on the measurements done during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Willing and able to sign informed consent form
- •Willingness to abstain from visiting a sauna during the study period
- •Willingness to dry area where the HealthDot is applied in a dipping fashion after washing
- •Willingness to abstain from flying during the study period of time
- •Elective surgery
- •General anesthesia required for surgery
排除标准
- •General inmates of psychiatric wards, prisons, or other state institutions
- •Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
- •Any skin condition, for example prior rash, discoloration, scars or open wounds at the area of investigation of both devices
- •Pregnant, or breastfeeding
- •Known to be allergic for the tissue adhesive used in the HealthDot.
- •Use of topical that is known to influence the skin at the test area (such as medical and non-medical creams or lotions)
- •Patient with active implantables such as Implantable Cardioverter Defibrilator (ICD) and pacemaker
- •Unable to understand instructions
- •Expected participation less than 2 weeks
- •Left lower rib (place where HealthDot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
- •Area on arm where the Elan device is applied is involved in the surgical procedure.
- •Patients with antibiotic resitant infections (e.g. MRSA).
研究组 & 干预措施
Elan and HealthDot
Patients with elective surgery will wear two devices (HealthDot and Elan) after surgery in hospital and after discharge at home for up to 2 weeks (HealthDot) or 3 weeks (Elan).
干预措施: Elan and HealthDot (Other)
结局指标
主要结局
Sensitivity and specificity
时间窗: 3 weeks
Evaluate the sensitivity and specificity for the prediction of deterioration after surgery using the data from both devices.
次要结局
- Accuracy Elan(3 weeks)
- Accuracy HealthDot(2 weeks)
- Comfort of wearing measured by questionnaire(at week 2)