On the PhonE Respiratory rAte Study (OPERA) (OPERA)
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)
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.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Isere
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La Tronche、Isere、法国、38700
- Grenoble University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age >18yo
- Dyspnea as main reason for consultation
- Regulated by "Centre 15"
- Admitted for less than 6hours at emergency department
Exclusion Criteria:
- Non invasive or tracheotomized ventilation
- Cognitive impairment
- Pregnancy
学习计划
研究是如何设计的?
设计细节
- 观测模型:其他
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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RRate app on the phone precision
大体时间:1 minute
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To compare withBland-Altman analysis the accuracy of the RRate measurement by phone to a one-minute respiratory rate measurement at patient's bedside
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1 minute
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Efficiency
大体时间:1 minute
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length of RR measurement according to the different methods used
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1 minute
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Measurement failure criteria by different Rrate methods (by phone, next to the patient and the reference method)
大体时间:1 minute
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Wether coughing, talking during measurement, phone hold by another person, has an impact on measurement possibility.
The gap between the measurement by different RRate methods (by phone, next to the patient and the reference method)
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1 minute
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Accuracy
大体时间:1 minute
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Bland Altman analysis : between one minute measurement at patient's bedside and other measurements : RRate app at patient's bedside, impedancemetry, traditional measurement during 15 seconds or 30 seconds
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1 minute
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Clinical impact
大体时间:1 minute
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qSOFA (sequential Organ Failure Assesment score) obtained with different measurement of the RRate at 60 second
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1 minute
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Reproducibility
大体时间:1 minute
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Coefficient of variation and Intra-class correlation, of respiratory rate measured twice with : RRate app on the phone, RRate app at patient's bedside, 15 seconds measurement.
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1 minute
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合作者和调查者
调查人员
- 首席研究员:Maxime MD Maignan, PhD、University Hospital, Grenoble
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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RRate Mobile app的临床试验
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Klein Buendel, Inc.National Institute on Minority Health and Health Disparities (NIMHD); Pennington Biomedical...完全的
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Environment and Health Group, Inc.Prisma Health完全的
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The Miriam HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)撤销
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VA Office of Research and Development尚未招聘