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

NCT06632197 | Not Yet Recruiting

• 1 other identifier: CAPNO-SVO2
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ventilatory Failure; Cardiac Failure; Mechanical Ventilation Pressure High

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cardiac output

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Hypoventilation; Heart Failure

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Isabel Magana Bru, MD

CONTACT

+34 915202200; isabelmgbru@gmail.com

Fernando Suarez Sipmann, MD, PdH

CONTACT

+34 915202200; fsuarezsipmann@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Intesive Care Medicine, Principal Investigator

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 8, 2024
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: August 1, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-10