A Pilot Feasibility Study of an Ambulatory Multi-Vital Signs Monitor in Perioperative Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Preoperative Caretaker Monitor Placement Success
研究概览
简要总结
The purpose of this research is evaluate vital signs (VS), which include non-invasive blood pressure, pulse rate, respiratory rate and Oxygen Saturation (SpO2) using a portable wrist monitoring device called a Caretaker. This device has been cleared by the Food and Drug Administration (FDA) for use and allows the study team to check vital signs in a participant's normal setting.
Participation in this study will involve wearing this portable device at 2 different time points:
- for up to 24 hours immediately during and after the participant's preoperative visit to obtain baseline vital signs during normal activity and during sleep and
- after surgery up to 24 hours while participant recovers prior to discharge from the hospital
详细描述
Anesthesiologists and surgeons examine vital signs such as heart rate (HR), respiratory rate (RR), oxygen saturation (SaO2) and blood pressure (BP) in an effort to detect extremes of altered VS and remediate these alterations prior to surgery and anesthesia. In most preoperative clinics, however, these VS are measured once and no further assessments are made until they arrive for their surgery. Patients with cardiac and pulmonary disease, however, can have highly variable VS.
The Caretaker device is a wrist device designed to measure relatively continuous VS over a period up to 24 hours. The device is accompanied by a finger cuff that measure pulse and respiratory rate, along with a non-invasive blood pressure detector and pulse oximeter. In an effort to detect VS that may not be recognized with the usual one-time measurement in the clinic, the study team plans to monitor ambulatory preoperative VS in patients who meet the study criteria, for up to 16-24 hours preoperatively. They will then return their device on the day of surgery.
Postoperatively, the study team will place a CareTaker device once again and measure these same VS in the same patients for up to 24 hours prior to discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Preoperative Caretaker Monitor Placement Success
时间窗: Baseline
Number of participants who had the presence of (data existing for at least 70% of 5-minute time periods) for all of the vital signs of interest together--heart rate (HR), blood pressure (BP), respiratory rate (RR), arterial oxygen saturation (SaO2) after placement of the device on the subject's wrist and hand.
Caretaker Data Capture Rate
时间窗: Post-Op Hour 24
Number of participants with no missing values expressed
Ease of Use Determined by Number of Participants With Sleep or Activities of Daily Living (ADLs) Interference
时间窗: Pre-Op Hour 24
Participants' description of ease of use (interfered with Activities of Daily Living (ADLs) or sleep) in Yes/No format. Data will be collected to demonstrate percent of patients who answered "Yes" to Sleep or ADL interference. Free text will also be recorded for qualitative purposes. Shows Caretaker Feasibility.
Postoperative Caretaker Healthcare Provider (HCP) Usability
时间窗: Post-Op Hour 24
Using postoperative nurse verbal feedback on usability of the Caretaker monitor on subjects scheduled for surgery during the perioperative period. Percent of nurses who answer yes to the question: Did you have any difficulty using the Caretaker monitor?
Monitor Return Rate
时间窗: Baseline through Pre-Op Hour 24
Percent of monitors returned to our research technicians
次要结局
- Heart Rate--percent of Time Parameters(Pre-Op Hour 24, Post-Op Hour 24)
- Respiratory Rate(Pre-Op hour 24, Post-Op Hour 24)
- SaO2--Percent of Time(Pre-Op Hour 24, Post-Op Hour 24)
- Non-Invasive Mean Arterial Blood Pressure (MBP)(Pre-Op Hour 24, Post-Op Hour 24)
- Non-Invasive Diastolic Blood Pressure (DBP)(Pre-Op Hour 24, Post-Op Hour 24)
- Arterial Oxygen Saturation (SaO2)(Post-Op Hour 24)
- Non-Invasive Systolic Blood Pressure (SBP)(Pre-Op Hour 24, Post-Op Hour 24)
- Non-Invasive Blood Pressure--MBP Percent of Time Parameters(Pre-Op Hour 24, Post-Op Hour 24)
- Number of Rapid Response Team Calls(During hospitalization up to Postoperative Day 30)
- Heart Rate(Pre-Op hour 24, Post-Op Hour 24)
- Respiratory Rate--Percent of Time Parameters(Pre-Op hour 24, Post-Op Hour 24)
- Mortality Rate(Day 30)
- Average Length of Hospital Stay(Up to Postoperative Day 30)
- ICU Transfer Rate(Up to Postoperative Day 30)