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Capnodynamic Monitoring of Cardiorespiratory Function in Critically Ill Patients

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05082168
Acronym
PROFICIENT
Enrollment
100
Registered
2021-10-18
Start date
2021-02-01
Completion date
2023-07-01
Last updated
2021-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Infection, Postoperative Respiratory Distress, Sepsis

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

Interventions

DEVICECapnodynamic 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.

Sponsors

South West Sydney Local Health District
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between capnodynamic effective pulmonary blood flow and cardiac output measured by pulmonary artery thermodilution or echocardiographyThrough study completion, an average of 1 yearCapnodynamic measurements of effective pulmonary blood flow are compared with contemporaneously obtained cardiac output measurements using clinical reference methods
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 yearCapnodynamic estimates of mixed venous oxygen saturation are compared with contemporaneously obtained blood gases from the pulmonary artery catheter
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 PEEPThrough study completion, an average of 1 yearAt 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

Countries

Australia

Contacts

Primary ContactAnders Aneman, Prof
anders.aneman@health.nsw.gov.au+61 (0)2 87383400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026