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临床试验/NCT06556797
NCT06556797招募中不适用

How to Differentiate Congestive and Non-congestive Dyspnea in the Emergency Department? Proof-of-concept Study on Microperfusion Analysis Via GapCO2

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
GapCO2

研究概览

简要总结

Patients presenting to the emergency department with acute dyspnea undergo arterial blood gas measurement and monitoring of transcutaneous capnography using the TCM5 monitor. The aim of this study is to determine whether GapCO2, the difference between transcutaneous and arterial pCO2 (PaCO2 - PtcCO2), is correlated with the congestive or non-congestive origin of dyspnea.

详细描述

Upon arrival at the emergency department, patients are placed in the vital emergency reception area for monitoring. An emergency physician will review the selection criteria and offer the patient participation. The information sheet will be provided to the patient along with a copy of the non-opposition form in case of patient agreement.

Before the introduction of any treatment, a TC 92 sensor is placed on the earlobe (or on the forehead if the earlobe is inaccessible), connected to a Radiometer TCM5 monitor, measuring SpO2 (Massimo technology), perfusion index, and transcutaneous capnography (PtcCO2).

After a 5-minute equilibration period, measurements were taken throughout the duration of patient management. Standard diagnostic and therapeutic management will be provided according to the attending physician's prescription. The attending physician won't consider PtcCO2 (nor GapCO2) measurements in patient management.

At the time of data analysis, an adjudication committee comprising 2 emergency physicians from the inclusion service but not involved in patient care will review the complete medical records of patients to determine whether dyspnea was of congestive or non-congestive origin.

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

  • Age ≥ 18 years
  • Patient presenting with acute dyspnea defined by a sensation of respiratory discomfort with at least one of the following criteria: RR ≥ 22 and/or SpO2 < 95%
  • Arterial blood gas sampling performed as part of care
  • Inclusion less than 1 hour after arrival time to the emergency department
  • Non-opposition to participation in the study

排除标准

  • Temperature greater than or equal to 37.5°C
  • Patient who has already received a diuretic or vasodilator treatment in the emergency department or by a prehospital medical team
  • Systolic blood pressure less than or equal to 100 mmHg and/or signs of peripheral hypoperfusion
  • Inability to express refusal to participate in the study

结局指标

主要结局

GapCO2

时间窗: Within 1 hour after enrolment

PaCO2 measured via arterial blood gas analysis - PtcCO2 measured via TCM5 monitor, at 37°C

次要结局

  • Diagnostic performance of GapCO2 at 37°C(Within 1 hour after enrolment)
  • Proportion of patients who underwent GapCO2 measurement among those who presented to the emergency department for dyspnea on the days of inclusion(up to 28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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