Cardiac SurgeryNCT07573306
Validation and Feasibility of Noninvasive Oxygen Delivery Index Monitoring in Cardiac Surgery Patients
An observational study of Cardiac Surgery, run by University of Minnesota at 1 site in United States.
Trial summary
This study will establish the feasibility and preliminary validity of real-time oxygen delivery index (DO₂i) monitoring using noninvasive hemoglobin (SpHb, Masimo) and minimally invasive cardiac output (FloTrac, Edwards) in cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- SpHb monitor
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2026to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults undergoing cardiac surgery
Who may be able to join
- Adults ≥ 18 years undergoing cardiac surgery
- Placement of pulmonary artery catheter with continuous cardiac output (CCO) as part of routine clinical care
- Placement of arterial line with FloTrac as part of routine clinical care
- Availability of ≥ 3 arterial blood gas samples at specified timepoints
Who cannot join
- Mechanical circulatory support planned or in use (IABP, Impella, ECMO)
- Patients without BOTH pulmonary artery catheter with CCO and arterial line with FloTrac
- Patients who are Research Opt-Out
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
Sherilyn Landree, 612-282-3705, landr184@umn.edu
About this study
This study will establish the feasibility and preliminary validity of real-time oxygen delivery index (DO₂i) monitoring using noninvasive hemoglobin (SpHb, Masimo) and minimally invasive cardiac output (FloTrac, Edwards) in cardiac surgery patients.
- Conditions
- Cardiac Surgery
- Being tested
- SpHb monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpHb monitorDevice
The SpHb monitor is an FDA approved device being used according to its approved indications. No additional invasive procedures, blood draws, or interventions are performed for research purposes.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery patients | The study uses a within-patient repeated-measures design, where each patient serves as their own control across the three timepoints. The following measures will be recorded:
* SpHb, Perfusion Index, SpO₂ from Masimo Radical-7 (timestamp to HH:MM:SS)
* FloTrac cardiac index from Edwards HemoSphere
* ABG hemoglobin, SaO₂, PaO₂, and lactate from ABL analyzer
* Continuous cardiac index from Swan-Ganz catheter
* Mean arterial pressure, heart rate and rhythm
* Patient temperature from the bladder
* Pressor requirements Receives: Device: SpHb monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement Between SpHb-Based and Pulmonary Artery Catheter Oxygen Delivery Index
Bias and 95% limits of agreement between monitor-derived DO₂i (calculated from continuous SpHb and FloTrac cardiac index) and pulmonary artery catheter DO₂i (calculated from arterial blood gas hemoglobin and Swan-Ganz cardiac index), analyzed using Bland-Altman method with mixed-effects modeling to account for repeated measures. Agreement is considered acceptable if percentage error is <30%.
Measured: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post-protamine
Secondary outcomes (6)
Directional Agreement for Changes in Oxygen Delivery Index
Four-quadrant concordance rate (with 15% exclusion zone) for directional changes in DO₂i between consecutive timepoints. Concordance is defined as agreement in direction of change (increase vs decrease) between monitor-derived and gold-standard DO₂i measurements. Scores range from 0- 100%, with higher percentages indicating better directional agreement.
Measured: Changes between consecutive intraoperative timepoints (baseline to post-heparin, post- heparin to post-protamine) during cardiac surgery
Correlation Between Oxygen Delivery Index and Arterial Lactate
Pearson or Spearman correlation coefficient between DO₂i (both monitor-derived and gold- standard) and simultaneously measured arterial lactate concentration. Correlation coefficients range from -1 to +1, with negative values indicating inverse relationship between DO₂i and lactate.
Measured: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
Agreement Between FloTrac and Swan-Ganz Cardiac Index
Percentage error between FloTrac arterial pressure-based cardiac index and Swan-Ganz thermodilution continuous cardiac index. Percentage error is calculated as (1.96 × SD of differences) / mean cardiac index × 100%. Agreement is considered acceptable if percentage error is <30%.
Measured: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
Impact of Baseline SpHb Calibration on Agreement
Comparison of limits of agreement before and after in vivo SpHb calibration (baseline- adjusted SpHb using first arterial blood gas hemoglobin value as reference). Measured as change in bias and 95% limits of agreement between uncalibrated and baseline-calibrated SpHb-based DO₂i compared to gold standard.
Measured: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
SpHb Signal Usability Rate
Percentage of planned timepoints with valid SpHb signal defined by perfusion index (PI) ≥ 0.5. Scores range from 0-100%, with 100% indicating valid signal at all timepoints.
Measured: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
Perfusion Index Threshold for Acceptable SpHb Accuracy
Minimum perfusion index value associated with acceptable SpHb accuracy, defined as SpHb bias within ±1 g/dL of arterial blood gas hemoglobin. Perfusion index values range from 0-20%, with higher values indicating better peripheral perfusion.
Measured: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start15 Dec 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Gorbaty, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573306
- Sponsor's protocol ID
- ANES-2026-34768
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Feasibility of Noninvasive Oxygen Delivery Index Monitoring in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT07573306
- Acronym / sponsor ID
- ANES-2026-34768
- Conditions
- Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 7 May 2026 (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.
This study will establish the feasibility and preliminary validity of real-time oxygen delivery index (DO₂i) monitoring using noninvasive hemoglobin (SpHb, Masimo) and minimally invasive cardiac output (FloTrac, Edwards) in cardiac surgery patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery patients | – | Device: SpHb monitorThe study uses a within-patient repeated-measures design, where each patient serves as their own control across the three timepoints. The following measures will be recorded: * SpHb, Perfusion Index, SpO₂ from Masimo Radical-7 (timestamp to HH:MM:SS) * FloTrac cardiac index from Edwards HemoSphere * ABG hemoglobin, SaO₂, PaO₂, and lactate from ABL analyzer * Continuous cardiac index from Swan-Ganz catheter * Mean arterial pressure, heart rate and rhythm * Patient temperature from the bladder * Pressor requirements |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing cardiac surgery
Key inclusion criteria (4 listed)
- Adults ≥ 18 years undergoing cardiac surgery
- Placement of pulmonary artery catheter with continuous cardiac output (CCO) as part of routine clinical care
- Placement of arterial line with FloTrac as part of routine clinical care
- Availability of ≥ 3 arterial blood gas samples at specified timepoints
Key exclusion criteria (3 listed)
- Mechanical circulatory support planned or in use (IABP, Impella, ECMO)
- Patients without BOTH pulmonary artery catheter with CCO and arterial line with FloTrac
- Patients who are Research Opt-Out
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpHb monitorThe SpHb monitor is an FDA approved device being used according to its approved indications. No additional invasive procedures, blood draws, or interventions are performed for research purposes. | Device | Cardiac surgery patients |
Primary outcome
Agreement Between SpHb-Based and Pulmonary Artery Catheter Oxygen Delivery Index
Time frame: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post-protamine
Bias and 95% limits of agreement between monitor-derived DO₂i (calculated from continuous SpHb and FloTrac cardiac index) and pulmonary artery catheter DO₂i (calculated from arterial blood gas hemoglobin and Swan-Ganz cardiac index), analyzed using Bland-Altman method with mixed-effects modeling to account for repeated measures. Agreement is considered acceptable if percentage error is <30%.
6 secondary outcomes
Directional Agreement for Changes in Oxygen Delivery Index
Time frame: Changes between consecutive intraoperative timepoints (baseline to post-heparin, post- heparin to post-protamine) during cardiac surgery
Correlation Between Oxygen Delivery Index and Arterial Lactate
Time frame: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
Agreement Between FloTrac and Swan-Ganz Cardiac Index
Time frame: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
Impact of Baseline SpHb Calibration on Agreement
Time frame: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
SpHb Signal Usability Rate
Time frame: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
Perfusion Index Threshold for Acceptable SpHb Accuracy
Time frame: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
Related trials for Cardiac Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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.
Benjamin Gorbaty, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by University of Minnesota at 1 site in United States.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherilyn Landree ((612) 282-3705, landr184@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between SpHb-Based and Pulmonary Artery Catheter Oxygen Delivery Index (time frame: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post-protamine). 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 19 Oct 2026.