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临床试验/NCT03393585
NCT03393585已完成不适用

Respiratory Rates - Accuracy of Contact-free Monitoring of Respiratory Rates in the Triage Setting of an Emergency Department

Christian Nickel1 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2017年12月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
650
试验地点
1
主要终点
Specificity and sensitivity of the camera based prototype application (CBPA)

研究概览

简要总结

Respiratory rate is an important predictor for many clinical outcomes in Emergency Medicine. Nevertheless it's measurement is often omitted as it is time-consuming and cumbersome. It is the only vital sign that is not routinely assessed by a device. In a pilot study was showed that a camera based monitoring system measures reliably respiratory rates in healthy volunteers.

The goal of this study is to test the accuracy of the same system in real patients in the triage setting of an Emergency Department (ED).

详细描述

For triage of emergency patients at the Emergency Department of the University Hospital Basel the emergency severity index (ESI) is used. At decision point "D" in the ESI-algorithm vital signs such as respiratory rate, heart rate and oxygen saturation are needed.

According to the guidelines the respiratory rate is visually counted for one minute (WHOrecommendation) by a triage nurse.

Simultaneously in addition to the visual counting, it is planned to measure the same vital sign as part of our study also through a camera-based prototype application (CBPA) and capnography as a gold standard.

Hence the triage process is not prolongated through our study, only completed and a guideline compliant procedure is ensured which is only performed in a relatively low percentage in the ED of the University Hospital Basel. Clinical decisions are exclusively based on the actual clinical standard of visual counting and are not influenced by the measurements of our study.

For the capnography, which were considered as the most accurate method, the patient wears a nasal sample line (Philips® Heartstart MRx mit Philips® Smart CapnoLine™PlusO2Long Oral/Nasal Sample Line).

研究设计

研究类型
Observational
观察模型
Other
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

入选标准

  • All walk-in patients older than 18 with a presumed ESI score of 2-3 presenting to the ED of the University Hospital of Basel will be eligible for inclusion.

排除标准

  • Excluded will be (1) patients brought in by ambulance or helicopter, (2) unstable patients needing immediate medical treatment, (3) confused, restless, deaf patients having difficulty to follow the study instructions (4) Clear signs of refusal to participate the study.

结局指标

主要结局

Specificity and sensitivity of the camera based prototype application (CBPA)

时间窗: 1 year

In this study respiratory rates are obtained by 3 methods. 1. Camera based measurement, 2. with capnography and 3. with the WHO criterion standard of counting breaths for 1 Minute (18 measurements in whole). We want to study the Specificity and sensitivity of the CBPA compared to the gold standard (capnography)

次要结局

  • Upgrade of patient's ESI level due to CBPA (from Level 3 to 2)(1 year)

研究者

发起方
Christian Nickel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christian Nickel

PD MD

University Hospital, Basel, Switzerland

研究点 (1)

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