Capnodynamic Monitoring of Cardiorespiratory Function in Critically Ill Patients

NCT05082168 | Unknown

• 1 other identifier: 2020/ETH00778
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Infection; Sepsis; Postoperative Respiratory Distress

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  Through study completion, an average of 1 year

Study Arms (3)

Respiratory tract infection

Patients diagnosed with viral or bacterial pneumonia and admitted to ICU for mechanical ventilatory support

Device: Capnodynamic monitoring

Sepsis

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

Device: Capnodynamic monitoring

Cardiac surgery

Patients admitted to ICU for mechanical ventilatory support following cardiac surgery

Device: Capnodynamic monitoring

Interventions

Capnodynamic monitoring DEVICE

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.

Also known as: thermodilution cardiac output measurement, echocardiography, blood gas analyses

Cardiac surgery; Respiratory tract infection; Sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to ICU for mechanical ventilation with a diagnosis of viral/bacterial pneumonia, sepsis or following cardiac surgery.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• South West Sydney Local Health District: lead

Study Sites (1)

Intensive Care Unit, Liverpool Hospital, South Western Sydney Local Health District

Liverpool, New South Wales, 1871, Australia

RECRUITING

Related Publications (2)

• 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.

  PMID: 37243954 DERIVED

• 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.

  PMID: 35909174 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Echocardiography; Blood Gas Analysis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Central Study Contacts

Anders Aneman, Prof

CONTACT

+61 (0)2 87383400; anders.aneman@health.nsw.gov.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Conj Professor UNSW, Director ICU Research, Senior Staff Specialist

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 18, 2021
• Study Start: February 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: July 1, 2023
• Last Updated: October 18, 2021

Record last verified: 2021-10

Locations

AU (1)