Validation and Feasibility of Noninvasive Oxygen Delivery Index Monitoring in Cardiac Surgery Patients
17 augusti 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
150
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Sherilyn Landree
- Telefonnummer: (612) 282-3705
- E-post: landr184@umn.edu
Studieorter
-
-
Minnesota
-
Minneapolis, Minnesota, Förenta staterna, 55455
- University of Minnesota
-
Kontakt:
- Sherilyn Landree
- Telefonnummer: 612-282-3705
- E-post: landr184@umn.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Adults undergoing cardiac surgery
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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:
|
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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Agreement Between SpHb-Based and Pulmonary Artery Catheter Oxygen Delivery Index
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Directional Agreement for Changes in Oxygen Delivery Index
Tidsram: Changes between consecutive intraoperative timepoints (baseline to post-heparin, post- heparin to post-protamine) during cardiac surgery
|
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
Tidsram: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
|
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
|
|
Agreement Between FloTrac and Swan-Ganz Cardiac Index
Tidsram: 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
Tidsram: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
|
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
Tidsram: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
|
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
|
|
Perfusion Index Threshold for Acceptable SpHb Accuracy
Tidsram: Three intraoperative timepoints during cardiac surgery: baseline, post-heparin, and post- protamine
|
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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Major Adverse Cardiac Events (Exploratory)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Benjamin Gorbaty, MD, University of Minnesota
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
15 oktober 2026
Primärt slutförande (Beräknad)
1 augusti 2027
Avslutad studie (Beräknad)
1 augusti 2027
Studieregistreringsdatum
Först inskickad
30 april 2026
Först inskickad som uppfyllde QC-kriterierna
30 april 2026
Första postat (Faktisk)
7 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- ANES-2026-34768
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
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