- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04885699
Validation of Capnodynamic Assessment of Mixed Venous Oxygen Saturation
Validation of Capnodynamic Assessment of Mixed Venous Oxygen Saturation and Cardiac Output in Anesthetized Children Undergoing Cardiac Catheterization
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jacob Karlsson, MD PhD
- Phone Number: +46851779245
- Email: jacob.karlsson.1@ki.se
Study Contact Backup
- Name: Per-Arne Lönnqvist
- Phone Number: +46851777000
- Email: per-arne.lonnqvist@ki.se
Study Locations
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Stockholm, Sweden, 171 64
- Recruiting
- Karolinska University Hospital
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Contact:
- Jacob Karlsson, MD PhD
- Phone Number: +46851779245
- Email: jacob.karlsson.1@ki.se
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Contact:
- Anders Svedmyr, MD
- Phone Number: 468517770000
- Email: anders.svedmyr@sll.se
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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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Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Agreement of absolute values between Capnodynamic cardiac output and the reference method modified CO2-Fick
Time Frame: 20 minutes
|
Comparing continuous capnodynamic measurement of effective pulmonary blood flow (cardiac output) and CO obtained by modified CO2-Fick.
|
20 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Per-Arne Lönnqvist, MD, Karolinska University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KarolinskaALB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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