Clinical trial NCT05082168: Capnodynamic Monitoring of Cardiorespiratory Function in Critically Ill Patients
Official title: Capnodynamic Monitoring of Cardiorespiratory Function in Patients Admitted to the Intensive Care Unit With COVID-19 Infection, Sepsis and Following Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Infection
Sepsis
Postoperative Respiratory Distress
Lead sponsor: South West Sydney Local Health District
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between capnodynamic effective pulmonary blood flow and cardiac output measured by pulmonary artery thermodilution or echocardiography
timeFrame: Through study completion, an average of 1 year
measure: Correlation between capnodynamic estimates of mixed venous oxygen saturation and blood gas analysis of blood obtained from the pulmonary artery pulmonary.
timeFrame: Through study completion, an average of 1 year
measure: 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
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: Australia
facility: Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District
state: New South Wales
Study officials:
References:
citation: 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.