Non-invasive Monitoring of Mixed Venous Oxygen Saturation Using the Capnodynamic Method in Adults (CAPNO-SVO2)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Failure; Ventilatory Failure; Mechanical Ventilation Pressure High

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Isabel Magana Bru, MD; Phone Number: +34 915202200; Email: isabelmgbru@gmail.com
• Study Contact Backup: Name: Fernando Suarez Sipmann, MD, PdH; Phone Number: +34 915202200; Email: fsuarezsipmann@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in the ICU of the Hospital Universitario de la Princesa.

The study population will include all patients with medical conditions (respiratory or cardiac) who could benefit from the placement of a PAC and/or the monitoring of mixed venous saturation for clinical management and decision-making, or monitoring of central venous saturation if a pulmonary artery catheter is not required.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac output	measured using the capnodynamic method in comparison with the invasive standard method using co-oximetry with a pulmonary artery catheter (PAC).	24 hours

Collaborators and Investigators

• Sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: October 6, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 10, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Heart Failure; Hypoventilation
• Other Study ID Numbers: CAPNO-SVO2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No