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Not yet recruitingNCT06632197CAPNO-SVO2Updated Oct 10, 2024

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

An observational study in Ventilatory Failure, Cardiac Failure and Mechanical Ventilation Pressure High, sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Ventilatory Failure
  • Cardiac Failure
  • Mechanical Ventilation Pressure High
03

In context

Hypoventilation

96 studies on the registry are indexed under Hypoventilation; 21 are open to participants now.

This study's planned enrollment of 25 is below the median of 74 across 28 observational studies indexed under Hypoventilation.

Browse Hypoventilation studies →

Lead sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa is the lead sponsor of 35 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Failure to obtain .
  • No need for invasive mechanical ventilation.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No
06

What researchers measure

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).

    Time frame: 24 hours

Secondary outcomes

  1. Cardiac output

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

    Time frame: 24 hours

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2024; primary completion for Dec 2024, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2024
First posted
Oct 8, 2024
StartEst.
Dec 2024
Primary completionEst.
Dec 2024
CompletionEst.
Aug 2025
Last update
Oct 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06632197
Lead sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Responsible party
Isabel Magaña Bru (MD Intesive Care Medicine, Principal Investigator, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa) — Principal investigator
First posted
Oct 8, 2024
Start date
Dec 2024 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Aug 2025 (estimated)
Last update
Oct 10, 2024

Study contacts

Isabel Magana Bru, MD
Contact
isabelmgbru@gmail.com
+34 915202200
Fernando Suarez Sipmann, MD, PdH
Contact
fsuarezsipmann@gmail.com
+34 915202200

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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