NCT04885699

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

January 16, 2025

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

May 9, 2021

Last Update Submit

January 14, 2025

Conditions

Cardiac Output, LowCardiac Output, High

Keywords

mixed venous oxygen saturationcapnodynamics

Outcome Measures

Primary Outcomes (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

    20 minutes

Secondary Outcomes (1)

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

    20 minutes

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Full term newborn children up till 18 years of age undergoing interventional/diagnostic cardiac catheterization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 171 64, Sweden

Location

MeSH Terms

Conditions

Cardiac Output, LowCardiac Output, High

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Per-Arne Lönnqvist, MD

    Karolinska University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2021

First Posted

May 13, 2021

Study Start

June 1, 2021

Primary Completion

June 1, 2023

Study Completion

October 1, 2023

Last Updated

January 16, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)