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临床试验/NCT04077593
NCT04077593已完成不适用

Evaluation de la précision d'Une Mesure téléphonique de la fréquence Respiratoire à l'Aide d'Une Application Mobile - The OPERA Study (On the PhonE Respiratory rAte)

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年10月21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
25
试验地点
1
主要终点
RRate app on the phone precision

研究概览

简要总结

Introduction. The increasing use of telephone medical advice requires the development of telemedicine tools to assess the patient's severity. Respiratory rate (RR) is a simple vital parameter and is often associated with morbidity and mortality of patients. There is no standardized measure of RR by telephone.

Objective: The investigators wanted to evaluate the RR measurement by phone using a smartphone application called RRate.

Methods. Adults who have been admitted for less than 6 hours to the emergency department after calling Center 15 and whose main reason for consultation is dyspnea will be included. Patients with non-invasive or tracheotomized ventilation will be excluded. The main objective will be to compare by Bland-Altman method the accuracy of the RRate measurement by phone to a one-minute RR measurement at patient's bedside. Secondary endpoints will evaluate the length of RR measurement according to the different methods used; measurement failure criteria; the accuracy of different measurement techniques (RRate at patient's bedside, impedancemetry, traditional measurement during 15s or 30s).

Expected Results. The accuracy of the RR measurement by RRate over the telephone should be within the limits of agreement. The measurement time should be shorter with the RRate application than with traditional methods. However, the measurement by telephone should not always be feasible in patients with mild dyspnea or with poorly audible breathing.

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

  • Age >18yo
  • Dyspnea as main reason for consultation
  • Regulated by "Centre 15"
  • Admitted for less than 6hours at emergency department

排除标准

  • Non invasive or tracheotomized ventilation
  • Cognitive impairment
  • Pregnancy

结局指标

主要结局

RRate app on the phone precision

时间窗: 1 minute

To compare withBland-Altman analysis the accuracy of the RRate measurement by phone to a one-minute respiratory rate measurement at patient's bedside

次要结局

  • Efficiency(1 minute)
  • Accuracy(1 minute)
  • Clinical impact(1 minute)
  • Reproducibility(1 minute)
  • Measurement failure criteria by different Rrate methods (by phone, next to the patient and the reference method)(1 minute)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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On the PhonE Respiratory rAte Study (OPERA) | 临床试验