NCT07573306Not yet recruitingNot Applicable
Validation and Feasibility of Noninvasive Oxygen Delivery Index Monitoring in Cardiac Surgery Patients
University of Minnesota1 site in 1 country150 target enrollmentStarted: October 15, 2026Last updated:
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Minnesota
- Enrollment
- 150
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: SpHb monitor (Device)
Investigators
Study Sites (1)
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