跳至主要内容
临床试验/NCT04064580
NCT04064580Unknown不适用

Analysis of the Capnography Curve Can Allow the Discrimination of Obstructive Patients - Modeling the Capnography Curve

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Spirometry measurement

研究概览

简要总结

Obstructive respiratory diseases such as asthma or COPD are a common reason for emergency room visits. Currently, nasal gill capnography and oxygen saturation measurement (SpO2) are the only two non-invasive means of continuously monitoring a respiratory pathology. To date, Respiratory Functional Explorations (CFE) and more particularly spirometry, are considered as the reference examinations for the diagnosis or monitoring of asthma or COPD. However, physical and physical constraints make their use almost impossible in the context of the emergency with patients presenting to emergencies in respiratory distress, often require oxygen therapy or even non-invasive ventilation. Only pulmonary auscultation can make the diagnosis of acute decompensation of obstructive pathology. This technique is qualitative and imprecise, sometimes leading to a diagnostic uncertainty resulting in delay in taking charge and inappropriate therapy.

Studies have shown a change in the capnography curve in obstructive airway disorder and a strong correlation between some capnography parameters and spirometry parameters such as the Tiffeneau ratio (FEV1 / FVC), suggesting capnography as a simple and effective technique for the diagnosis of obstructive syndrome of patients in emergencies.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Major patient male or female
  • Patient with respiratory disease with and without obstructive syndrome or patient without respiratory pathology
  • Patient requiring spirometry breathing functional exploration
  • Subject affiliated to a social health insurance scheme
  • Subject able to understand the objectives and the risks related to the research and to give its non opposition

排除标准

  • Pregnant and lactating woman
  • Patient not affiliated to a social protection scheme
  • Subject in exclusion period (determined by previous or current study),
  • Impossibility of giving the subject information enlightened (subject in emergency situation, difficulties of understanding the subject, ...)
  • Subject under the protection of justice Subject under guardianship or curatorship

结局指标

主要结局

Spirometry measurement

时间窗: 1 day

Tiffenau Report Compendium (FEV1 / FVC) and FEV1 for spirometry (gold standard defining presence of obstructive disorder). Collection of the capnography curves of each patient allowing in a second time to perform an analysis of the curve by different methods.

次要结局

未报告次要终点

研究者

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

研究点 (1)

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