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

NCT07573306 | Not Yet Recruiting FDA Device

• 1 other identifier: ANES-2026-34768
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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%.

  Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post-protamine

Secondary Outcomes (6)

• Directional Agreement for Changes in Oxygen Delivery Index

  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

  Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine

• Agreement Between FloTrac and Swan-Ganz Cardiac Index

  Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine

• Impact of Baseline SpHb Calibration on Agreement

  Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine

• SpHb Signal Usability Rate

  Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine

Other Outcomes (2)

• Major Adverse Cardiac Events (Exploratory)

  Within 30 days of surgery

• Acute Kidney Injury (Exploratory)

  Within 30 days of surgery

Study Arms (1)

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

Interventions

SpHb monitor DEVICE

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.

Cardiac surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing cardiac surgery

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

• Benjamin Gorbaty, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherilyn Landree

CONTACT

(612) 282-3705; landr184@umn.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 7, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

US (1)