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临床试验/NCT05240079
NCT05240079Unknown不适用

Evaluation of Concordance Between the Measurements Obtained by an Acquisition System of Physiological Parameters (Heart Rate/SpO2) Via a Teleconsultation Camera System With Reference to Standard Acquisition Measurements

Central Hospital, Nancy, France0 个研究点目标入组 200 人开始时间: 2022年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
Caducy's heart rate measurement compared to standard

研究概览

简要总结

Caducy is a new medical device that is able to estimate physiological number such as heart rate and SpO2 via laptop or computer camera. The goal of this study is to evaluate the concordance of Caducy system in reference to gold standard which is a heart rate monitor and an oximeter pod linked to a station of acquisition regardless the human variability. The Caducy system measurement via camera is made by filming the visage of the patient during 1 minute.

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
是

入选标准

  • •Be 18 years of age or over.
  • •Patient affiliated to a social security scheme.
  • •Having received complete information on the organization of the research.
  • •Able to understand the requirements of the trial and having signed a free and informed consent prior to entering the study
  • •Patient taken care of by the CUMSAPA (Centre Universitaire de Médecine du Sport et Activité Physique Adaptées) service for an PFT (pulmonary function test), stress test, consultation of adapted physical activity or other functional explorations carried out by the service.
  • •Patient having carried out a preliminary clinical examination.

排除标准

  • •Acute phenomenon contra-indicating the performance of an PFT, stress test or other functional exploration.
  • •Person with tremors at the time of clinical examination (Parkinson, spasms...)
  • •People who cannot present the palms of both hands (amputation).
  • •Woman of childbearing age who does not have effective contraception.
  • •Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code: Pregnant woman, parturient or nursing mother, Minor (non-emancipated), Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice), Person of full age unable to express consent
  • •Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1.

研究组 & 干预措施

Patients

Experimental

干预措施: Heart rate measurement with Caducy system (twice). SpO2 measurement with Caducy system (Twice). (Device)

结局指标

主要结局

Caducy's heart rate measurement compared to standard

时间窗: through study completion, an average of 6 month

Heart rate (bpm) taken with gold standart Heart rate (bpm) calculated by CADUCY

次要结局

  • Caducy's SpO2 measurement compared to standard(through study completion, an average of 6 month)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

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