跳至主要内容
临床试验/NCT04045262
NCT04045262已完成不适用

Clinical Validation of Continuous and Non-invasive Monitoring of Effective Pulmonary Volume Based on Exhaled CO2 Kinetics in Ventilated Patients.

Fernando Suarez Sipmann1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2019年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
85
试验地点
1
主要终点
Trending ability of the capnodynamic end-expiratory lung volume method

研究概览

简要总结

The aim of this study is to evaluate/validate a new non-invasive method to continuously monitor effective lung volume in critically ill patients.

详细描述

The capnodinamyc method is a new monitoring method that provides continuous (breath by breath) measurements of effective pulmonary blood flow (EPBF) and effective end-expiratory l lung volume (EELVCO2). The former refers to the non-shunted fraction of cardiac output and the latter to the functional end-expiratory lung volume (EELV) that contains CO2.

The capnodynamic method is based on the advanced analysis of CO2 kinetics and the law of Conservation of mass. It states that lungs have to eliminate a similar amounts of CO2 as produced by aerobic metabolism and reaches the lung via pulmonary perfusion. For its calculation, two different measurements are needed:

  1. Exhaled CO2 measured by infrared optic sensor technology placed in a mainstream configuration between the endotracheal tube and the "Y" piece of the ventilator respiratory circuit.
  2. Flow, airway pressure and ventilatory volumes measured by the mechanical ventilator spirometer.

The method requires the generation of cyclic small changes in the alveolar concentration of CO2 which is achieved by introducing a slightly modified breathing pattern. It consists of adding a short expiratory hold in each 3 out of 9 consecutive breaths and requires the patient to be in passive breathing conditions under mechanical ventilation.

EPBF and EELVCO2 have been validated in experimental conditions and the first validations in patients in the setting of general anesthesia are under way.

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

  • All patients on mechanical ventilation in passive breathing conditions in which a thoracic CTscan has been indicated for medical reasons and those with an EIT and a continuous cardiac monitoring
  • Informed consent

排除标准

  • Hemodynamic instability
  • Presence of barotrauma/ pneumothorax
  • Presence of bronchopleural fistulas
  • Thorax alterations that preclude the positioning of the EIT electrode belt (usually at the IV intercostal space).

结局指标

主要结局

Trending ability of the capnodynamic end-expiratory lung volume method

时间窗: 1 day

Breath by breath changes in EELVCO2 will be compared with breath by breath changes in lung aeration measured by electrical impedance tomography.

Validation of the measurement of absolute values of effective lung volume

时间窗: 1 day

To validate the measurement of absolute values of effective lung volume by the capnodynamic method previously described, as an estimate of end-expiratory lung volume. For this purpose the capnodynamic method will be compared with gold standard reference method for measuring lung volumes, the computerized tomography scan (CTscan).

Improvement of capnodynamic ELV measurement

时间窗: 1 day

To determine the effects of lung collapse on the accuracy and precision of the capnodynamic ELV measurement.

Analyze to which pulmonary compartments does effective lung volume most closely correlate

时间窗: 1 day

Tomographic aeration level according to the density distribution analysis (non aerated, poorly aerated, normally and hyper aerated) does effective lung volume most closely correlate; taking into account that the CTscan measures an anatomic rather than a functional lung volume.

次要结局

未报告次要终点

研究者

发起方
Fernando Suarez Sipmann
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fernando Suarez Sipmann

MD PhD Intesive Care Medicine

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

研究点 (1)

Loading locations...

相似试验