Capnodynamic Monitoring of Cardiorespiratory Function in Critically Ill Patients (PROFICIENT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Acute Respiratory Infection; Postoperative Respiratory Distress
• Intervention / Treatment: Device: Capnodynamic monitoring

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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Anders Aneman, Prof; Phone Number: +61 (0)2 87383400; Email: anders.aneman@health.nsw.gov.au

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 1871
      • Recruiting
      • Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to ICU for mechanical ventilation with a diagnosis of viral/bacterial pneumonia, sepsis or following cardiac surgery.

Description

Inclusion Criteria:

Respiratory tract infection:

1. confirmed or highly suspected viral or bacterial pneumonia
2. meeting ARF or ARDS criteria as outlines in the most recent Berlin ARDS consensus statement
3. age 18 years or above
4. arterial and central venous catheters have been inserted or will be inserted as part of routine clinical management
5. mechanical ventilation via an endotracheal tube is expected to continue for the day beyond day of admission
6. adequate transthoracic echocardiographic winds are available to measure the velocity time integral in the left ventricular outflow tract
7. 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

Sepsis:

1. admitted to ICU with a provisional or established diagnosis of septic shock as defined by the Sepsis-3 criteria
2. age 18 years or above
3. arterial and central venous catheters have been inserted or will be inserted as part of routine clinical management
4. mechanical ventilation via an endotracheal tube is expected to continue for at least another two hours
5. adequate transthoracic echocardiographic winds are available to measure the velocity time integral in the left ventricular outflow tract
6. 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
7. the administration of a fluid bolus (250 ml or 500 ml) is indicated as judged by the medical officer supervising routine management

Cardiac surgery:

1. admitted to ICU following cardiac surgery using cardiopulmonary bypass
2. age 18 years and above
3. arterial, central venous and pulmonary arterial catheters have been inserted or will be inserted as part of routine clinical management
4. mechanical ventilation via an endotracheal tube is expected to continue for at least another two hours
5. 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
6. the administration of a fluid bolus (250 ml or 500 ml) is indicated as judged by the medical officer supervising routine postoperative management

Exclusion Criteria:

In all cohorts:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Respiratory tract infection; Patients diagnosed with viral or bacterial pneumonia and admitted to ICU for mechanical ventilatory support	Device: Capnodynamic monitoring; In patients fully synchronized with mechanical ventilation, the capnodynamic method calculates the effective pulmonary blood flow, the end-expiratory lung volume and estimates the mixed venous oxygen saturation. The capnodynamic method uses short inspiratory or expiratory pauses to induce small changes in CO2 concentration the enable the mole balance to be resolved for the capnodynamic equation: ELV x [(FACO2(n)-FACO2(n-1)] = delta(n) x EPBF [CvCO2(n)] - VTCO2.; Other Names: echocardiography; thermodilution cardiac output measurement; blood gas analyses
Sepsis; Patients diagnosed with sepsis and admitted to ICU for mechanical ventilatory support	Device: Capnodynamic monitoring; In patients fully synchronized with mechanical ventilation, the capnodynamic method calculates the effective pulmonary blood flow, the end-expiratory lung volume and estimates the mixed venous oxygen saturation. The capnodynamic method uses short inspiratory or expiratory pauses to induce small changes in CO2 concentration the enable the mole balance to be resolved for the capnodynamic equation: ELV x [(FACO2(n)-FACO2(n-1)] = delta(n) x EPBF [CvCO2(n)] - VTCO2.; Other Names: echocardiography; thermodilution cardiac output measurement; blood gas analyses
Cardiac surgery; Patients admitted to ICU for mechanical ventilatory support following cardiac surgery	Device: Capnodynamic monitoring; In patients fully synchronized with mechanical ventilation, the capnodynamic method calculates the effective pulmonary blood flow, the end-expiratory lung volume and estimates the mixed venous oxygen saturation. The capnodynamic method uses short inspiratory or expiratory pauses to induce small changes in CO2 concentration the enable the mole balance to be resolved for the capnodynamic equation: ELV x [(FACO2(n)-FACO2(n-1)] = delta(n) x EPBF [CvCO2(n)] - VTCO2.; Other Names: echocardiography; thermodilution cardiac output measurement; blood gas analyses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between capnodynamic effective pulmonary blood flow and cardiac output measured by pulmonary artery thermodilution or echocardiography	Capnodynamic measurements of effective pulmonary blood flow are compared with contemporaneously obtained cardiac output measurements using clinical reference methods	Through study completion, an average of 1 year
Correlation between capnodynamic estimates of mixed venous oxygen saturation and blood gas analysis of blood obtained from the pulmonary artery pulmonary.	Capnodynamic estimates of mixed venous oxygen saturation are compared with contemporaneously obtained blood gases from the pulmonary artery catheter	Through study completion, an average of 1 year
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	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	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: South West Sydney Local Health District

Publications and helpful links

General Publications

• Schulz L, Stewart A, O'Regan W, McCanny P, Austin D, Hallback M, Wallin M, Aneman A. Capnodynamic monitoring of lung volume and blood flow in response to increased positive end-expiratory pressure in moderate to severe COVID-19 pneumonia: an observational study. Crit Care. 2022 Jul 31;26(1):232. doi: 10.1186/s13054-022-04110-0.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Infections; Respiratory Tract Infections
• Other Study ID Numbers: 2020/ETH00778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Upon reasonable request, IPD may be shared if fully compliant with HREC requirements and European GRDP regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No