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Clinical Trials/NCT05082168
NCT05082168
Unknown
Not Applicable

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 site in 1 country100 target enrollmentFebruary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Respiratory Infection
Sponsor
South West Sydney Local Health District
Enrollment
100
Locations
1
Primary Endpoint
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
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
February 1, 2021
End Date
July 1, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
South West Sydney Local Health District
Responsible Party
Principal Investigator
Principal Investigator

Anders Aneman

Conj Professor UNSW, Director ICU Research, Senior Staff Specialist

South West Sydney Local Health District

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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.

Time Frame: 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

Time Frame: 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

Study Sites (1)

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