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
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.
- 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