Acute Respiratory InfectionPROFICIENTNCT05082168
Capnodynamic Monitoring of Cardiorespiratory Function in Critically Ill Patients
An observational study of Acute Respiratory Infection and Sepsis, run by South West Sydney Local Health District at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Infection, Sepsis, Postoperative Respiratory Distress
- What is being tested?
- Capnodynamic monitoring
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Feb 2021to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to ICU for mechanical ventilation with a diagnosis of viral/bacterial pneumonia, sepsis or following cardiac surgery.
Who may be able to join
- Respiratory tract infection:
- confirmed or highly suspected viral or bacterial pneumonia
- meeting ARF or ARDS criteria as outlines in the most recent Berlin ARDS consensus statement
- age 18 years or above
- arterial and central venous catheters have been inserted or will be inserted as part of routine clinical management
- mechanical ventilation via an endotracheal tube is expected to continue for the day beyond day of admission
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- adequate transthoracic echocardiographic winds are available to measure the velocity time integral in the left ventricular outflow tract
- 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:
- admitted to ICU with a provisional or established diagnosis of septic shock as defined by the Sepsis-3 criteria
- age 18 years or above
- arterial and central venous catheters have been inserted or will be inserted as part of routine clinical management
- mechanical ventilation via an endotracheal tube is expected to continue for at least another two hours
- adequate transthoracic echocardiographic winds are available to measure the velocity time integral in the left ventricular outflow tract
- 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
- the administration of a fluid bolus (250 ml or 500 ml) is indicated as judged by the medical officer supervising routine management
- Cardiac surgery:
- admitted to ICU following cardiac surgery using cardiopulmonary bypass
- age 18 years and above
- arterial, central venous and pulmonary arterial catheters have been inserted or will be inserted as part of routine clinical management
- mechanical ventilation via an endotracheal tube is expected to continue for at least another two hours
- 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
- the administration of a fluid bolus (250 ml or 500 ml) is indicated as judged by the medical officer supervising routine postoperative management
Who cannot join
- In all cohorts:
- age under 18 years
- known pregnancy
- arterial and central venous catheters are not indicated as part of routine care
- known severe valvulopathy
- ongoing or imminent need for mechanical circulatory support
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- severe haemodynamic instability with imminent transfer for intervention(s) outside ICU
- patient is not for full active management in ICU
- patient is not expected to live beyond the day of admission
- patient is re-admitted to ICU within the same index hospital admission
- it is not possible to achieve full patient-ventilator synchrony
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District
Liverpool, New South Wales, 1871
Anders Aneman, MD, PhD, +61 2 8738 3400, anders.aneman@swsahs.nsw.gov.au
About this study
Official title: Capnodynamic Monitoring of Cardiorespiratory Function in Patients Admitted to the Intensive Care Unit With COVID-19 Infection, Sepsis and Following Cardiac Surgery
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.
Read the detailed description
This study aims to:
- compare the estimation of cardiac output (CO) using the capnodynamic method (COEPBF) with contemporary reference methods;
- compare the estimation of mixed venous oxygen saturation (SmvO2) with invasively obtained blood gas analyses;
- generate observational data on end-expiratory lung volume (EELV) when ventilator settings, and in particular PEEP, are changed;
- combine 1-3 to provide a physiological construct of cardiorespiratory function
- Being tested
- Capnodynamic monitoring
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capnodynamic monitoringDevice
Also called thermodilution cardiac output measurement, echocardiography, blood gas analyses
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.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory tract infection | Patients diagnosed with viral or bacterial pneumonia and admitted to ICU for mechanical ventilatory support Receives: Device: Capnodynamic monitoring | |
| Sepsis | Patients diagnosed with sepsis and admitted to ICU for mechanical ventilatory support Receives: Device: Capnodynamic monitoring | |
| Cardiac surgery | Patients admitted to ICU for mechanical ventilatory support following cardiac surgery Receives: Device: Capnodynamic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between capnodynamic effective pulmonary blood flow and cardiac output measured by pulmonary artery thermodilution or echocardiography
Capnodynamic measurements of effective pulmonary blood flow are compared with contemporaneously obtained cardiac output measurements using clinical reference methods
Measured: Through study completion, an average of 1 year
Correlation between capnodynamic estimates of mixed venous oxygen saturation and blood gas analysis of blood obtained from the pulmonary artery pulmonary.
Capnodynamic estimates of mixed venous oxygen saturation are compared with contemporaneously obtained blood gases from the pulmonary artery catheter
Measured: Through study completion, an average of 1 year
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
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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start1 Feb 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South West Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Aneman, South West Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082168
- Sponsor's protocol ID
- 2020/ETH00778
- Acronym
- PROFICIENT
- Status last verified
- Oct 2021
- First submitted
- 20 Sep 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request, IPD may be shared if fully compliant with HREC requirements and European GRDP regulations
Publications
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.
PubMed 37243954Schulz 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.
PubMed 35909174
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capnodynamic Monitoring of Cardiorespiratory Function in Patients Admitted to the Intensive Care Unit With COVID-19 Infection, Sepsis and Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05082168
- Acronym / sponsor ID
- PROFICIENT / 2020/ETH00778
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- South West Sydney Local Health DistrictUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- compare the estimation of cardiac output (CO) using the capnodynamic method (COEPBF) with contemporary reference methods;
- compare the estimation of mixed venous oxygen saturation (SmvO2) with invasively obtained blood gas analyses;
- generate observational data on end-expiratory lung volume (EELV) when ventilator settings, and in particular PEEP, are changed;
- combine 1-3 to provide a physiological construct of cardiorespiratory function
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Respiratory tract infection | – | Device: Capnodynamic monitoringPatients diagnosed with viral or bacterial pneumonia and admitted to ICU for mechanical ventilatory support |
| Sepsis | – | Device: Capnodynamic monitoringPatients diagnosed with sepsis and admitted to ICU for mechanical ventilatory support |
| Cardiac surgery | – | Device: Capnodynamic monitoringPatients admitted to ICU for mechanical ventilatory support following cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to ICU for mechanical ventilation with a diagnosis of viral/bacterial pneumonia, sepsis or following cardiac surgery.
Key inclusion criteria (23 listed)
- confirmed or highly suspected viral or bacterial pneumonia
- meeting ARF or ARDS criteria as outlines in the most recent Berlin ARDS consensus statement
- age 18 years or above
- arterial and central venous catheters have been inserted or will be inserted as part of routine clinical management
- mechanical ventilation via an endotracheal tube is expected to continue for the day beyond day of admission
Key exclusion criteria (11 listed)
- age under 18 years
- known pregnancy
- arterial and central venous catheters are not indicated as part of routine care
- known severe valvulopathy
- ongoing or imminent need for mechanical circulatory support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capnodynamic monitoringAlso: thermodilution cardiac output measurement, echocardiography, blood gas analysesIn 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. | Device | Cardiac surgery, Respiratory tract infection, Sepsis |
Primary outcome
Correlation between capnodynamic effective pulmonary blood flow and cardiac output measured by pulmonary artery thermodilution or echocardiography
Time frame: 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
Correlation between capnodynamic estimates of mixed venous oxygen saturation and blood gas analysis of blood obtained from the pulmonary artery pulmonary.
Time frame: 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
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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Derived from this study: PubMed 37243954Keleher 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.
- Derived from this study: PubMed 35909174Schulz 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.
- Individual participant dataSharing planned: Undecided. Upon reasonable request, IPD may be shared if fully compliant with HREC requirements and European GRDP regulations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Infection and Sepsis, run by South West Sydney Local Health District at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anders Aneman, Prof (+61 (0)2 87383400, anders.aneman@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between capnodynamic effective pulmonary blood flow and cardiac output measured by pulmonary artery thermodilution or echocardiography (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05082168, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.