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临床试验/NCT06602089
NCT06602089已完成不适用

Finger-sensor and Oscillometric Versus Intra-arterial Blood Pressure Measurements: a Method Comparison in Patients Having Non-cardiac Surgery

University of Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Difference in the agreement between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements, and the agreement between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements

研究概览

简要总结

This is an observational study simultaneously comparing finger-sensor and oscillometric with intra-arterial blood pressure measurements in patients having low- to moderate-risk non-cardiac surgery.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • ≥18 years
  • scheduled for elective low- to moderate-risk non-cardiac surgery with general anesthesia
  • planned intraarterial arterial pressure monitoring with a radial arterial catheter

排除标准

  • systolic arterial pressure interarm differences >20 mmHg
  • heart rhythms other than sinus rhythm
  • contraindications for finger-sensor arterial pressure monitoring (e.g., arteriovenous shunts, Raynaud's disease)
  • surgery in non-supine positions
  • pregnant patients.

结局指标

主要结局

Difference in the agreement between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements, and the agreement between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements

时间窗: During surgery

To investigate whether the agreement between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements (mean arterial pressure, systolic arterial pressure, and diastolic arterial pressure) is better than the agreement between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements, we will perform Bland-Altman analyses.

次要结局

  • Classification of measurement differences between finger-sensor arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance(During surgery)
  • Classification of measurement differences between oscillometric arterial pressure measurements and intraarterial arterial pressure measurements according to their clinical importance(During surgery)
  • Ability of finger-sensor arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring(During surgery)
  • Ability of oscillometric arterial pressure monitoring to track arterial pressure changes compared to intraarterial arterial pressure monitoring(During surgery)

研究者

发起方
University of Hamburg-Eppendorf
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Alina Bergholz

Principal Investigator

University of Hamburg-Eppendorf

研究点 (2)

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