Validation and Feasibility of Noninvasive Oxygen Delivery Index Monitoring in Cardiac Surgery Patients

April 30, 2026 updated by: University of Minnesota
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults undergoing cardiac surgery

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Device: SpHb monitor
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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%.
Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post-protamine

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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%.
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
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.
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
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.
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
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.
Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events (Exploratory)
Time Frame: Within 30 days of surgery
Composite endpoint including all-cause mortality, myocardial infarction (elevated troponin with ECG changes or clinical symptoms), stroke (new neurologic deficit with imaging confirmation), or urgent revascularization.
Within 30 days of surgery
Acute Kidney Injury (Exploratory)
Time Frame: Within 30 days of surgery
AKI defined and staged using KDIGO criteria based on postoperative serum creatinine changes: Stage 1 (1.5-1.9× baseline or ≥0.3 mg/dL increase), Stage 2 (2.0-2.9× baseline), Stage 3 (≥3× baseline or ≥4.0 mg/dL or initiation of renal replacement therapy).
Within 30 days of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Benjamin Gorbaty, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANES-2026-34768

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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