Menu
Not yet recruiting NCT07573306

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

— Observational Cardiac Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SpHb monitor.
Who it may be relevant to
Registry conditions: Cardiac Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (6)
  • 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]
  • Correlation Between Oxygen Delivery Index and Arterial Lactate [Time frame: 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]
  • Impact of Baseline SpHb Calibration on Agreement [Time frame: 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]
  • Perfusion Index Threshold for Acceptable SpHb Accuracy [Time frame: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT07573306 · ANES-2026-34768

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗