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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07573306
Status
Not Yet Recruiting

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Conditions

  • Cardiac Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: 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

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Sherilyn Landree
[email protected]
612-282-3705

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By research site
University of Minnesota· Minneapolis, MN

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