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临床试验/NCT06719518
NCT06719518尚未招募不适用

Performance Evaluation of the ViTrack Continuous Non-invasive Blood Pressure Measurement Device

The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Comparison of Diastolic Blood Pressure

研究概览

简要总结

The purpose of this study is to calibrate the ViTrack™ arterial pressure waveform against intra-arterial pressure (IAP) in dynamic clinical settings and to assess the optimized ViTrack™ design to measure and continuously track blood pressure over a wide, clinically-relevant pressure range.

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

  • scheduled to undergo noncardiac surgery with general or spinal anesthesia
  • clinical indication for invasive intra-arterial pressure monitoring
  • palpable pulse

排除标准

  • difference of greater than 10 mmHg in the left versus right arm oscillometric systolic blood pressure
  • Upper extremity arteriovenous hemodialysis shunt
  • Upper extremity amputation
  • Planned surgical position/draping that precludes access to the wrist
  • Wrist distortion or pain from arthritis
  • Prior trauma or surgery at the radial artery monitoring site
  • Unable to provide informed consent
  • Clinical contraindication as determined by the clinical team or study investigators

结局指标

主要结局

Comparison of Diastolic Blood Pressure

时间窗: From start of surgery up to 24 hours after surgery

255 time points compared across continuous blood pressure (mmHg)

Comparison of Systolic Blood Pressure

时间窗: From start of surgery up to 24 hours after surgery

255 time points compared across continuous blood pressure (mmHg)

次要结局

  • Number of participants who show signs of Skin Irritation(From start of surgery up to 72 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehmet Turan

Professor

The University of Texas Health Science Center, Houston

研究点 (1)

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