Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06632197

Non-invasive Monitoring of Mixed Venous Oxygen Saturation Using the Capnodynamic Method in Adults

The objective of this study is to compare the accuracy and correlation of the capnodynamic method for measuring mixed venous oxygen saturation (SvO2) with the standard reference method (pulmonary artery catheter), with the potential for the capnodynamic method to replace the traditional method in selected cases.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

The main objective is to evaluate the accuracy and correlation of mixed venous oxygen saturation (SvO2) measured using the capnodynamic method in comparison with the invasive standard method using co-oximetry with a pulmonary artery catheter (PAC) Swan-Ganz, with the potential to replace it in selected cases, in patients who would benefit from hemodynamic monitoring with PAC for their clinical management and decision-making.

The investigator will also study the following secondary objectives:

  • To assess whether the capnodynamic method (Capno-SvO2) detects changes over time in the studied variable (SvO2), showing good concordance and magnitude compared to the reference method.
  • To evaluate the progression and trend of the Capno-SvO2 method in different clinical situations, such as in adult respiratory distress syndrome and patients with other respiratory pathologies, as well as patients with cardiac conditions.
  • To assess the ability of the Capno-SvO2 method to detect changes in mixed venous oxygen saturation in response to therapeutic interventions (e.g., adjustments in mechanical ventilation, use of inotropes, vasopressors, or fluid therapy) or moderate hemodynamic changes.
  • To evaluate the correlation between mixed venous oxygen saturation measured using the Capno-SvO2 method and other hemodynamic parameters, such as cardiac output, central venous pressure, and cardiac index.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Not participating in any other interventional study at the time of the study.
  • Patients under controlled mechanical ventilation in passive conditions.
  • Situations where the responsible physician deems that, for the benefit of clinical management and therapeutic decision-making, the patient would benefit from the placement of a pulmonary artery catheter (Swan-Ganz) and/or monitoring of central or mixed venous saturation.
  • Obtaining informed consent.

Exclusion criteria

  • Failure to obtain informed consent.
  • No need for invasive mechanical ventilation.

Treatment and study plan

Primary outcomes

  1. Mixed venous oxygen saturation (SvO2)

    Time frame: 24 hours

    measured using the capnodynamic method in comparison with the invasive standard method using co-oximetry with a pulmonary artery catheter (PAC).

Secondary outcomes

  1. Cardiac output

    Time frame: 24 hours

    measured using the capnodynamic method in comparison with the invasive standard method using co-oximetry with a pulmonary artery catheter (PAC).

Study contacts

Contact information is provided by the study sponsor or research team.

Fernando Suarez Sipmann, MD, PdH

CONTACT

[email protected]

+34 915202200

Isabel Magana Bru, MD

CONTACT

[email protected]

+34 915202200

Sponsors and collaborators

Lead sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Other

Registry information

Acronym: CAPNO-SVO2

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.