PROFICIENT: Capnodynamic Monitoring of Cardiorespiratory Function in Critically Ill Patients

Sponsor
South West Sydney Local Health District (Other)
Overall Status
Recruiting
CT.gov ID
NCT05082168
Collaborator
(none)
100
1
28.9
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Capnodynamic Monitoring of Cardiorespiratory Function in Patients Admitted to the Intensive Care Unit With COVID-19 Infection, Sepsis and Following Cardiac Surgery
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm 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:
  • thermodilution cardiac output measurement
  • echocardiography
  • 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:
  • thermodilution cardiac output measurement
  • echocardiography
  • 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:
  • thermodilution cardiac output measurement
  • echocardiography
  • blood gas analyses
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District Liverpool New South Wales Australia 1871

    Sponsors and Collaborators

    • South West Sydney Local Health District

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anders Aneman, Conj Professor UNSW, Director ICU Research, Senior Staff Specialist, South West Sydney Local Health District
    ClinicalTrials.gov Identifier:
    NCT05082168
    Other Study ID Numbers:
    • 2020/ETH00778
    First Posted:
    Oct 18, 2021
    Last Update Posted:
    Oct 18, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 18, 2021