Capnodynamic Monitoring of Cardiorespiratory Function in Critically Ill Patients
NCT ID: NCT05082168
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2021-02-01
2023-07-01
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Respiratory tract infection
Patients diagnosed with viral or bacterial pneumonia and admitted to ICU for mechanical ventilatory support
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.
Sepsis
Patients diagnosed with sepsis and admitted to ICU for mechanical ventilatory support
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.
Cardiac surgery
Patients admitted to ICU for mechanical ventilatory support following cardiac surgery
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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South West Sydney Local Health District
OTHER
Responsible Party
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Anders Aneman
Conj Professor UNSW, Director ICU Research, Senior Staff Specialist
Locations
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Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District
Liverpool, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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References
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Keleher E, Iftikhar H, Schulz LF, McCanny P, Austin D, Stewart A, O'Regan W, Hallback M, Wallin M, Aneman A. Capnodynamic monitoring of lung volume and pulmonary blood flow during alveolar recruitment: a prospective observational study in postoperative cardiac patients. J Clin Monit Comput. 2023 Dec;37(6):1463-1472. doi: 10.1007/s10877-023-01033-1. Epub 2023 May 27.
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.
Other Identifiers
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2020/ETH00778
Identifier Type: -
Identifier Source: org_study_id