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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05082168




Registration number
NCT05082168
Ethics application status
Date submitted
20/09/2021
Date registered
18/10/2021
Date last updated
18/10/2021

Titles & IDs
Public title
Capnodynamic Monitoring of Cardiorespiratory Function in Critically Ill Patients
Scientific title
Capnodynamic Monitoring of Cardiorespiratory Function in Patients Admitted to the Intensive Care Unit With COVID-19 Infection, Sepsis and Following Cardiac Surgery
Secondary ID [1] 0 0
2020/ETH00778
Universal Trial Number (UTN)
Trial acronym
PROFICIENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Respiratory Infection 0 0
Sepsis 0 0
Postoperative Respiratory Distress 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Capnodynamic monitoring

Respiratory tract infection - Patients diagnosed with viral or bacterial pneumonia and admitted to ICU for mechanical ventilatory support

Sepsis - Patients diagnosed with sepsis and admitted to ICU for mechanical ventilatory support

Cardiac surgery - Patients admitted to ICU for mechanical ventilatory support following cardiac surgery


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Correlation between capnodynamic effective pulmonary blood flow and cardiac output measured by pulmonary artery thermodilution or echocardiography
Timepoint [1] 0 0
Through study completion, an average of 1 year
Primary outcome [2] 0 0
Correlation between capnodynamic estimates of mixed venous oxygen saturation and blood gas analysis of blood obtained from the pulmonary artery pulmonary.
Timepoint [2] 0 0
Through study completion, an average of 1 year
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
Through study completion, an average of 1 year

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District - Liverpool
Recruitment postcode(s) [1] 0 0
1871 - Liverpool

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05082168
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anders Aneman, Prof
Address 0 0
Country 0 0
Phone 0 0
+61 (0)2 87383400
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05082168