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临床试验/NCT06632197
NCT06632197尚未招募不适用

Non-invasive Monitoring of Mixed Venous Oxygen Saturation Using the Capnodynamic Method in Adults

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa0 个研究点目标入组 25 人开始时间: 2024年12月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
主要终点
Mixed venous oxygen saturation (SvO2)

研究概览

简要总结

The objective of this study is to compare the accuracy and correlation of the capnodynamic method for measuring mixed venous oxygen saturation (SvO2) with the standard reference method (pulmonary artery catheter), with the potential for the capnodynamic method to replace the traditional method in selected cases.

详细描述

The main objective is to evaluate the accuracy and correlation of mixed venous oxygen saturation (SvO2) measured using the capnodynamic method in comparison with the invasive standard method using co-oximetry with a pulmonary artery catheter (PAC) Swan-Ganz, with the potential to replace it in selected cases, in patients who would benefit from hemodynamic monitoring with PAC for their clinical management and decision-making.

The investigator will also study the following secondary objectives:

  • To assess whether the capnodynamic method (Capno-SvO2) detects changes over time in the studied variable (SvO2), showing good concordance and magnitude compared to the reference method.
  • To evaluate the progression and trend of the Capno-SvO2 method in different clinical situations, such as in adult respiratory distress syndrome and patients with other respiratory pathologies, as well as patients with cardiac conditions.
  • To assess the ability of the Capno-SvO2 method to detect changes in mixed venous oxygen saturation in response to therapeutic interventions (e.g., adjustments in mechanical ventilation, use of inotropes, vasopressors, or fluid therapy) or moderate hemodynamic changes.
  • To evaluate the correlation between mixed venous oxygen saturation measured using the Capno-SvO2 method and other hemodynamic parameters, such as cardiac output, central venous pressure, and cardiac index.

研究设计

研究类型
Observational
观察模型
Case Only
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
  • Not participating in any other interventional study at the time of the study.
  • Patients under controlled mechanical ventilation in passive conditions.
  • Situations where the responsible physician deems that, for the benefit of clinical management and therapeutic decision-making, the patient would benefit from the placement of a pulmonary artery catheter (Swan-Ganz) and/or monitoring of central or mixed venous saturation.
  • Obtaining informed consent.

排除标准

  • Failure to obtain informed consent.
  • No need for invasive mechanical ventilation.

结局指标

主要结局

Mixed venous oxygen saturation (SvO2)

时间窗: 24 hours

measured using the capnodynamic method in comparison with the invasive standard method using co-oximetry with a pulmonary artery catheter (PAC).

次要结局

  • Cardiac output(24 hours)

研究者

发起方
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Isabel Magaña Bru

MD Intesive Care Medicine, Principal Investigator

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

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