Ventilatory FailureCAPNO-SVO2NCT06632197
Non-invasive Monitoring of Mixed Venous Oxygen Saturation Using the Capnodynamic Method in Adults
An observational study of Ventilatory Failure and Cardiac Failure, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilatory Failure, Cardiac Failure, Mechanical Ventilation Pressure High
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Failure to obtain informed consent.
- No need for invasive mechanical ventilation.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Medical subject headings
- Hypoventilation, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilatory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel Magaña Bru, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632197
- Sponsor's protocol ID
- CAPNO-SVO2
- Acronym
- CAPNO-SVO2
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Monitoring of Mixed Venous Oxygen Saturation Using the Capnodynamic Method in Adults
- ClinicalTrials.gov ID
- NCT06632197
- Acronym / sponsor ID
- CAPNO-SVO2 / CAPNO-SVO2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Failure to obtain informed consent.
- No need for invasive mechanical ventilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Cardiac output
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilatory Failure and Cardiac Failure, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabel Magana Bru, MD (+34 915202200, isabelmgbru@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mixed venous oxygen saturation (SvO2) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.