Capnodynamic Monitoring of Cardiorespiratory Function in Critically Ill Patients

• Conditions: Acute Respiratory Infection; Postoperative Respiratory Distress; Sepsis
• Interventions: Device: Capnodynamic monitoring

• Registration Number: NCT05082168
• Lead Sponsor: South West Sydney Local Health District

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

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-09-20
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-14
• Last Update Submitted: 2021-10-14
• Study First Posted: 2021-10-18
• Last Update Posted: 2021-10-18
• Primary Completion: 2022-12-31
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Respiratory tract infection	Capnodynamic monitoring	Patients diagnosed with viral or bacterial pneumonia and admitted to ICU for mechanical ventilatory support
Cardiac surgery	Capnodynamic monitoring	Patients admitted to ICU for mechanical ventilatory support following cardiac surgery
Sepsis	Capnodynamic monitoring	Patients diagnosed with sepsis and admitted to ICU for mechanical ventilatory support

Primary Outcome Measures

Name	Time	Method
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	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.	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	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

Trial Locations

Locations (1)

Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District; 🇦🇺 Liverpool, New South Wales, Australia