Validation and Feasibility of Noninvasive Oxygen Delivery Index Monitoring in Cardiac Surgery Patients
17 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Estimé)
150
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Sherilyn Landree
- Numéro de téléphone: (612) 282-3705
- E-mail: landr184@umn.edu
Lieux d'étude
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota
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Contact:
- Sherilyn Landree
- Numéro de téléphone: 612-282-3705
- E-mail: landr184@umn.edu
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Adults undergoing cardiac surgery
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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:
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Agreement Between SpHb-Based and Pulmonary Artery Catheter Oxygen Delivery Index
Délai: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post-protamine
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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%.
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Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post-protamine
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Directional Agreement for Changes in Oxygen Delivery Index
Délai: Changes between consecutive intraoperative timepoints (baseline to post-heparin, post- heparin to post-protamine) during cardiac surgery
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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.
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Changes between consecutive intraoperative timepoints (baseline to post-heparin, post- heparin to post-protamine) during cardiac surgery
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Correlation Between Oxygen Delivery Index and Arterial Lactate
Délai: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
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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.
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Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
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Agreement Between FloTrac and Swan-Ganz Cardiac Index
Délai: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
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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%.
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Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
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Impact of Baseline SpHb Calibration on Agreement
Délai: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
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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.
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Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
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SpHb Signal Usability Rate
Délai: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
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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.
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Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
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Perfusion Index Threshold for Acceptable SpHb Accuracy
Délai: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
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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.
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Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Major Adverse Cardiac Events (Exploratory)
Délai: Within 30 days of surgery
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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.
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Within 30 days of surgery
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Acute Kidney Injury (Exploratory)
Délai: Within 30 days of surgery
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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).
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Within 30 days of surgery
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Benjamin Gorbaty, MD, University of Minnesota
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
15 octobre 2026
Achèvement primaire (Estimé)
1 août 2027
Achèvement de l'étude (Estimé)
1 août 2027
Dates d'inscription aux études
Première soumission
30 avril 2026
Première soumission répondant aux critères de contrôle qualité
30 avril 2026
Première publication (Réel)
7 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 août 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- ANES-2026-34768
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
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