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Clinical Trials/NCT04885699
NCT04885699CompletedNot Applicable

Validation of Capnodynamic Assessment of Mixed Venous Oxygen Saturation and Cardiac Output in Anesthetized Children Undergoing Cardiac Catheterization

Karolinska Institutet1 site in 1 country29 target enrollmentStarted: June 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
29
Locations
1
Primary Endpoint
Capnodynamic Mixed venous oxygen saturation vs CO-oximetry

Study Overview

Brief 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 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
0 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Agreement of absolute values between Capnodynamic cardiac output and the reference method modified CO2-Fick(20 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jacob Karlsson

Principal Investigator

Karolinska Institutet

Study Sites (1)

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