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临床试验/NCT07573306
NCT07573306尚未招募不适用

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

University of Minnesota1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年10月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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

干预措施: SpHb monitor (Device)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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