Evaluation of SenseGuard™ - a Noninvasive Respiratory Rate Measuring Device for Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Accuracy of Respiratory Rate (RR) as measured by the SenseGuard™ system versus the gold standard (capnography).
研究概览
简要总结
The SenseGuard™ is a new respiratory rate measuring and logging non-invasive device, and measures the respiratory rate by responding to changes in air moisture content in exhaled air. A prospective single-center, single arm study, designed to assess the bias, accuracy , precision and safety of the SenseGuard™ device in measuring of respiratory rate in adult patients. The study shall include a single invitational visit with a respiratory rate measurement duration of 30 minutes for each of 25 adult subjects hospitalized in internal wards.Subjects will be invited to participate should they meet all of the eligibility criteria. Following informed consent, subjects will be measured with both Microstream capnograph and SenseGuard™ measuring simultaneously so their results can be compared.
详细描述
Study description:
Respiratory rate (RR) is a vital sign used to monitor clinical condition of a patient. It is defined as the number of breaths per minute. Various devices using different techniques are available to measure RR. Currently this is measured at the bedside in clinical practice by counting the breaths, however the gold standard for measuring this vital sign is the capnograph. For the patient, this involves limiting the movement and talking so that the measurements can be taken.
A new respiratory rate measuring and logging device, SenseGuard™, is non-invasive and measures the respiratory rate by responding to changes in air moisture content (small amounts of water condensation) in exhaled air.
The study is planned as a prospective single-center, single arm study, designed to assess the bias, accuracy , precision and safety of the SenseGuard™ non-invasive device in measuring of respiratory rate in adult patients.
Subjects will be invited to participate should they meet all of the eligibility criteria. Following informed consent, subjects will be measured with both Microstream capnograph and SenseGuard™ measuring simultaneously so their results can be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Hospitalized patients from the Internal/General wards.
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged ≥18
- •Willing to adhere to the study regimen
排除标准
- •Intubated patients (i.e. endobronchial intubation) or patients currently undergoing a BPAP/CPAP treatment.
- •Presence of implanted electronic device intended to regulate cardiac activity (e.g., pacemaker or cardioverter/defibrillator)
- •Pregnancy or lactation
- •Known allergic reactions to materials used in the components of the SenseGuard™ system, i.e. polyethylene or silicon, or gold, nickel, copper or alloys containing any of the above.
- •Participation in another study in the last 4 weeks
研究组 & 干预措施
Respiratory rate measurement
Simultaneous measurement of respiratory rate using SenseGuard and Capnography
干预措施: SenseGuard (Device)
结局指标
主要结局
Accuracy of Respiratory Rate (RR) as measured by the SenseGuard™ system versus the gold standard (capnography).
时间窗: 4 months
Frequency and incidence of any adverse events and serious adverse events related and unrelated to the device use
时间窗: 4 months
次要结局
- Usability (comfort and easiness) score of the SenseGuard™ system as measured by a questionnaire completed by the subjects(4 months)