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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

-

Exclusion Criteria: ongoing ECMO treatment or intracardiac shunts not subjected to intervention. Weight less than 3.5 kg. Single ventricle circulation.

-

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Karolinska University Hospital

    Stockholm, 171 64

Other trials in Sweden

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.

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.

  1. 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)
  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.

  1. First posted13 May 2021
  2. Study start1 Jun 2021
  3. Primary completion1 Jun 2023
  4. Study completion1 Oct 2023

Resources

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)
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

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.

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