Validation and Feasibility of Noninvasive Oxygen Delivery Index Monitoring in Cardiac Surgery Patients
2026年4月30日 更新者：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.
調査の概要
研究の種類
観察的
入学 (推定)
150
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Sherilyn Landree
- 電話番号：(612) 282-3705
- メール：landr184@umn.edu
研究場所
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota
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コンタクト：
- Sherilyn Landree
- 電話番号：612-282-3705
- メール：landr184@umn.edu
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Adults undergoing cardiac surgery
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Agreement Between SpHb-Based and Pulmonary Artery Catheter Oxygen Delivery Index
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Directional Agreement for Changes in Oxygen Delivery Index
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Major Adverse Cardiac Events (Exploratory)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Benjamin Gorbaty, MD、University of Minnesota
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年8月1日
研究の完了 (推定)
2027年8月1日
試験登録日
最初に提出
2026年4月30日
QC基準を満たした最初の提出物
2026年4月30日
最初の投稿 (実際)
2026年5月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月7日
QC基準を満たした最後の更新が送信されました
2026年4月30日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- ANES-2026-34768
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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