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临床试验/NCT05082168
NCT05082168Unknown不适用

Capnodynamic Monitoring of Cardiorespiratory Function in Patients Admitted to the Intensive Care Unit With COVID-19 Infection, Sepsis and Following Cardiac Surgery

South West Sydney Local Health District1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Prediction by capnodynamic monitoring of combined changes in end expiratory lung volume and effective pulmonary blood flow to assess changes in pulmonary gas exchange during various levels of PEEP

研究概览

简要总结

Capnodynamic monitoring has the potential to offer continuous and non-invasive measurements of heart and lung function in patients requiring ventilation in an intensive care setting. Since mechanical ventilation with full patient synchronization is commonly used in ICU, capnodynamic monitoring can be immediately embedded in clinical care and compared to current methods of monitoring cardiac output, lung volumes and oxygen delivery. This observational study will explore capnodynamic monitoring in mechanically ventilated patients with a range of cardiorespiratory compromise.

详细描述

This study aims to:

  1. compare the estimation of cardiac output (CO) using the capnodynamic method (COEPBF) with contemporary reference methods;
  2. compare the estimation of mixed venous oxygen saturation (SmvO2) with invasively obtained blood gas analyses;
  3. generate observational data on end-expiratory lung volume (EELV) when ventilator settings, and in particular PEEP, are changed;
  4. combine 1-3 to provide a physiological construct of cardiorespiratory function

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

  • Respiratory tract infection:
  • confirmed or highly suspected viral or bacterial pneumonia
  • meeting ARF or ARDS criteria as outlines in the most recent Berlin ARDS consensus statement
  • age 18 years or above
  • arterial and central venous catheters have been inserted or will be inserted as part of routine clinical management
  • mechanical ventilation via an endotracheal tube is expected to continue for the day beyond day of admission
  • adequate transthoracic echocardiographic winds are available to measure the velocity time integral in the left ventricular outflow tract
  • analgosedation is administered as part of routine management of residual neuromuscular blockaded initiated outside ICU OR the administration of analgosedation and/or neuromuscular blockers at doses that achieve full patient-ventilator synchrony are considered part of routine clinical management
  • admitted to ICU with a provisional or established diagnosis of septic shock as defined by the Sepsis-3 criteria
  • age 18 years or above
  • arterial and central venous catheters have been inserted or will be inserted as part of routine clinical management
  • mechanical ventilation via an endotracheal tube is expected to continue for at least another two hours
  • adequate transthoracic echocardiographic winds are available to measure the velocity time integral in the left ventricular outflow tract
  • analgosedation is administered as part of routine management of residual neuromuscular blockaded initiated outside ICU OR the administration of analgosedation and/or neuromuscular blockers at doses that achieve full patient-ventilator synchrony are considered part of routine clinical management
  • the administration of a fluid bolus (250 ml or 500 ml) is indicated as judged by the medical officer supervising routine management
  • Cardiac surgery:
  • admitted to ICU following cardiac surgery using cardiopulmonary bypass
  • age 18 years and above
  • arterial, central venous and pulmonary arterial catheters have been inserted or will be inserted as part of routine clinical management
  • mechanical ventilation via an endotracheal tube is expected to continue for at least another two hours
  • analgosedation is administered as part of routine management of residual neuromuscular blockade initiated intraoperatively OR the administration of analgosedation and/or neuromuscular blockers at doses that achieve full patient-ventilator synchrony are considered part of routine clinical management
  • the administration of a fluid bolus (250 ml or 500 ml) is indicated as judged by the medical officer supervising routine postoperative management

排除标准

  • In all cohorts:
  • age under 18 years
  • known pregnancy
  • arterial and central venous catheters are not indicated as part of routine care
  • known severe valvulopathy
  • ongoing or imminent need for mechanical circulatory support
  • severe haemodynamic instability with imminent transfer for intervention(s) outside ICU
  • patient is not for full active management in ICU
  • patient is not expected to live beyond the day of admission
  • patient is re-admitted to ICU within the same index hospital admission
  • it is not possible to achieve full patient-ventilator synchrony

结局指标

主要结局

Prediction by capnodynamic monitoring of combined changes in end expiratory lung volume and effective pulmonary blood flow to assess changes in pulmonary gas exchange during various levels of PEEP

时间窗: Through study completion, an average of 1 year

At three different levels of PEEP, the interactions between end expiratory lung volume and effective pulmonary blood flow will be assessed and correlated to changes in arterial partial pressure of oxygen and carbon dioxide

Correlation between capnodynamic estimates of mixed venous oxygen saturation and blood gas analysis of blood obtained from the pulmonary artery pulmonary.

时间窗: Through study completion, an average of 1 year

Capnodynamic estimates of mixed venous oxygen saturation are compared with contemporaneously obtained blood gases from the pulmonary artery catheter

Correlation between capnodynamic effective pulmonary blood flow and cardiac output measured by pulmonary artery thermodilution or echocardiography

时间窗: Through study completion, an average of 1 year

Capnodynamic measurements of effective pulmonary blood flow are compared with contemporaneously obtained cardiac output measurements using clinical reference methods

次要结局

未报告次要终点

研究者

发起方
South West Sydney Local Health District
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anders Aneman

Conj Professor UNSW, Director ICU Research, Senior Staff Specialist

South West Sydney Local Health District

研究点 (1)

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