Cardiac Output, LowNCT04885699
Validation of Capnodynamic Assessment of Mixed Venous Oxygen Saturation
An observational study of Cardiac Output, Low and Cardiac Output, High, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Mixed venous saturation (SvO2) is an indicator of the balance between oxygen supply and demand in the body's tissues Recently, our research team published a paper describing the possibility to continuously monitor SvO2 by the use of continuous dynamic capnography (Karlsson et al, A Continuous Noninvasive Method to… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Cardiac Output, Low, Cardiac Output, High
- How many people
- 29 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2021to 1 Oct 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Full term newborn children up till 18 years of age undergoing interventional/diagnostic cardiac catheterization
Inclusion Criteria: Patients undergoing percutaneous intervention of cardiac conditions such as closure of atrial septal defect, persistent ductus arteriosus, pulmonary artery stenosis and diagnostic catheterization after heart transplant.
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Exclusion Criteria: ongoing ECMO treatment or intracardiac shunts not subjected to intervention. Weight less than 3.5 kg. Single ventricle circulation.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Capnodynamic Assessment of Mixed Venous Oxygen Saturation and Cardiac Output in Anesthetized Children Undergoing Cardiac Catheterization
Mixed venous saturation (SvO2) is an indicator of the balance between oxygen supply and demand in the body's tissues Recently, our research team published a paper describing the possibility to continuously monitor SvO2 by the use of continuous dynamic capnography (Karlsson et al, A Continuous Noninvasive Method to Assess Mixed Venous Oxygen Saturation: A Proof-of-Concept Study in Pigs. Anesth Analg 2020) The primary objective of the current study is thus to investigate the agreement and trending ability for capnodynamically derived SvO2 against the gold standard CO-oximetry. The secondary objective is to investigate the agreement and trending ability for capnodynamically derived CO (COEPBF) against the modified CO2-Fick method.
Read the detailed description
Background: Mixed venous saturation (SvO2) is an indicator of the balance between oxygen supply and demand in the body's tissues The primary objective of the current study is thus to investigate the agreement and trending ability for capnodynamically derived SvO2 against the gold standard CO-oximetry. The secondary objective is to investigate the agreement and trending ability for capnodynamically derived CO (COEPBF) against the modified CO2-Fick method.
Methods:
The rationale of capnodynamic SvO2 (capno-SvO2) can be briefly described as follows:
The Capno-SvO2 method is based on differential Fick's principle and utilizes a combination of continuous estimation of Effective Pulmonary Blood Flow (COEPBF) and oxygen consumption (VO2) incorporated in a rearranged Fick's equation. COEPBF is estimated by applying a special breathing pattern of variations in I:E relationships (six breaths with normal I:E relations followed by three breaths vid an approximately 2 s expiratory pause). This breathing pattern causes small fluctuations in alveolar CO2 concentration and VCO2, related to the pulmonary blood flow participating in gas exchange which allows for estimation of COEPBF. VO2 can be estimated using continuous volumetric capnography measurement of VCO2 combined with the Respiratory Quotient (RQ).
Modified CO2-Fick: CO estimation using modified CO2-Fick is assessed by incorporating measured CO2 content in mixed venous and arterial blood into the equation below where VCO2 is estimated using volumetric capnography.
COFick=VCO2/(CvCO2-CcCO2)
Study protocol
All patients planned for percutaneous intervention of cardiac conditions at our department will be screened for inclusion in this study. Exclusion criteria: ongoing ECMO treatment or intracardiac shunts not subjected to intervention. All these patients are routinely anaesthetized, intubated with a cuffed endotracheal tube and kept on controlled ventilation, a prerequisite for the capnodynamic method.
After induction of anesthesia, the special breathing pattern will be applied and continuous data from the capnodynamic monitoring will be collected. After catheterization of the pulmonary artery two baseline blood gases from the PAC and arterial line will be drawn and analyzed, and the hemoglobin level (Hb) from this sample will be used for calibration of the capnodynamic method together with a tabulated RQ. After completion of the interventional procedure, a sequence of paired testing of SvO2 from blood gases drawn from the pulmonary artery and arterial line. Firstly 2 samples (3 min apart) forming a baseline. After this follows a short increase in PEEP (3 cmH2O to 8cmH2O), which temporarily decreases cardiac output and SvO2. A sample is collected and then once more after PEEP has been brought back to 3 cmH2O after 3 minutes. Next, a raised level of inhaled oxygen from 30 to 80% (FiO2) is applied for 3 minutes and then turned back to baseline. Mixed venous and arterial samples will be drawn at FiO2 30% and 80%.
Paired recordings of COEPBF and CO2-Fick as well as capnodynamic SvO2 and co-oximetry will be examined for agreement and ability to detect change using Bland-Altman and four quadrant plots.
Power analyses (power 80% and alfa of 0.05) implies a minimal of 120 paired recordings corresponding to approximately 20 patients. 30 patients will be included for upward margin.
- Conditions
- Cardiac Output, Low, Cardiac Output, High
- Keywords
- mixed venous oxygen saturation, capnodynamics
- Medical subject headings
- Cardiac Output, Low, Cardiac Output, High
What is being measured
The primary outcome is the main question the study is designed to answer.
Capnodynamic Mixed venous oxygen saturation vs CO-oximetry
Agreement of absolute values between Capnodynamic Mixed venous oxygen saturation and the reference method CO-oximetry
Measured: 20 minutes
Secondary outcomes (1)
Agreement of absolute values between Capnodynamic cardiac output and the reference method modified CO2-Fick
Comparing continuous capnodynamic measurement of effective pulmonary blood flow (cardiac output) and CO obtained by modified CO2-Fick.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Jun 2021
- Primary completion1 Jun 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob Karlsson, Karolinska Institutet
- Investigators
- Per-Arne Lönnqvist, MD, Study chair, Karolinska University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885699
- Sponsor's protocol ID
- KarolinskaALB
- Status last verified
- Oct 2024
- First submitted
- 9 May 2021
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Capnodynamic Assessment of Mixed Venous Oxygen Saturation and Cardiac Output in Anesthetized Children Undergoing Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT04885699
- Acronym / sponsor ID
- KarolinskaALB
- Conditions
- Cardiac Output, Low, Cardiac Output, High
- Keywords
- mixed venous oxygen saturation, capnodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 13 May 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.
Mixed venous saturation (SvO2) is an indicator of the balance between oxygen supply and demand in the body's tissues Recently, our research team published a paper describing the possibility to continuously monitor SvO2 by the use of continuous dynamic capnography (Karlsson et al, A Continuous Noninvasive Method to Assess Mixed Venous Oxygen Saturation: A Proof-of-Concept Study in Pigs. Anesth Analg 2020) The primary objective of the current study is thus to investigate the agreement and trending ability for capnodynamically derived SvO2 against the gold standard CO-oximetry. The secondary objective is to investigate the agreement and trending ability for capnodynamically derived CO (COEPBF) against the modified CO2-Fick method.
Detailed description
Background: Mixed venous saturation (SvO2) is an indicator of the balance between oxygen supply and demand in the body's tissues The primary objective of the current study is thus to investigate the agreement and trending ability for capnodynamically derived SvO2 against the gold standard CO-oximetry. The secondary objective is to investigate the agreement and trending ability for capnodynamically derived CO (COEPBF) against the modified CO2-Fick method.
Methods:
The rationale of capnodynamic SvO2 (capno-SvO2) can be briefly described as follows:
The Capno-SvO2 method is based on differential Fick's principle and utilizes a combination of continuous estimation of Effective Pulmonary Blood Flow (COEPBF) and oxygen consumption (VO2) incorporated in a rearranged Fick's equation. COEPBF is estimated by applying a special breathing pattern of variations in I:E relationships (six breaths with normal I:E relations followed by three breaths vid an approximately 2 s expiratory pause). This breathing pattern causes small fluctuations in alveolar CO2 concentration and VCO2, related to the pulmonary blood flow participating in gas exchange which allows for estimation of COEPBF. VO2 can be estimated using continuous volumetric capnography measurement of VCO2 combined with the Respiratory Quotient (RQ).
Modified CO2-Fick: CO estimation using modified CO2-Fick is assessed by incorporating measured CO2 content in mixed venous and arterial blood into the equation below where VCO2 is estimated using volumetric capnography.
COFick=VCO2/(CvCO2-CcCO2)
Study protocol
All patients planned for percutaneous intervention of cardiac conditions at our department will be screened for inclusion in this study. Exclusion criteria: ongoing ECMO treatment or intracardiac shunts not subjected to intervention. All these patients are routinely anaesthetized, intubated with a cuffed endotracheal tube and kept on controlled ventilation, a prerequisite for the capnodynamic method.
After induction of anesthesia, the special breathing pattern will be applied and continuous data from the capnodynamic monitoring will be collected. After catheterization of the pulmonary artery two baseline blood gases from the PAC and arterial line will be drawn and analyzed, and the hemoglobin level (Hb) from this sample will be used for calibration of the capnodynamic method together with a tabulated RQ. After completion of the interventional procedure, a sequence of paired testing of SvO2 from blood gases drawn from the pulmonary artery and arterial line. Firstly 2 samples (3 min apart) forming a baseline. After this follows a short increase in PEEP (3 cmH2O to 8cmH2O), which temporarily decreases cardiac output and SvO2. A sample is collected and then once more after PEEP has been brought back to 3 cmH2O after 3 minutes. Next, a raised level of inhaled oxygen from 30 to 80% (FiO2) is applied for 3 minutes and then turned back to baseline. Mixed venous and arterial samples will be drawn at FiO2 30% and 80%.
Paired recordings of COEPBF and CO2-Fick as well as capnodynamic SvO2 and co-oximetry will be examined for agreement and ability to detect change using Bland-Altman and four quadrant plots.
Power analyses (power 80% and alfa of 0.05) implies a minimal of 120 paired recordings corresponding to approximately 20 patients. 30 patients will be included for upward margin.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Full term newborn children up till 18 years of age undergoing interventional/diagnostic cardiac catheterization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Capnodynamic Mixed venous oxygen saturation vs CO-oximetry
Time frame: 20 minutes
Agreement of absolute values between Capnodynamic Mixed venous oxygen saturation and the reference method CO-oximetry
1 secondary outcome
Agreement of absolute values between Capnodynamic cardiac output and the reference method modified CO2-Fick
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Per-Arne Lönnqvist, MD study chair
Karolinska University
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 Cardiac Output, Low and Cardiac Output, High, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 16 Jan 2025. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capnodynamic Mixed venous oxygen saturation vs CO-oximetry (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2025.