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临床试验/NCT02059928
NCT02059928已完成不适用

Intraosseous Pressure Monitoring in Intensive Care Unit Patients

HealthPartners Institute2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure

研究概览

简要总结

In emergency situations, access to the venous system is essential in order to administer fluids and medication and to monitor patients. When peripheral veins are difficult to access or the patient's condition requires certain medications, or monitoring, central venous catheters (CVC) are inserted. CVC placement introduces a much higher level of risk compared to peripheral catheters. The technique of intraosseous (IO) infusion has been used by healthcare professionals for several decades, but recently has gained wide popularity in the emergency care settings. This technique allows providers to secure a needle in the bony matrix at the ends of long bones (tibia and humerus) and infuse fluids and medications into the intramedullary space. The ability to monitor a patient's blood pressure through an intraosseous needle is unknown. The primary objective of this study is to describe the relationship (ratio) of intraosseous pressure (IOP) values to standard pressure values, including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and central venous pressure (CVP).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Patients ≥ 18 years old
  • Admitted to the surgical intensive care units
  • Current central pressure monitoring through a central line
  • Patient currently intubated and sedated
  • Informed consent obtained from family member
  • English speaking patient

排除标准

  • Known implanted devices in the humerus or tibia that prohibit placement of the intraosseous needle.
  • Known osteoporosis, avascular necrosis, or other bone pathology affecting bone healing.
  • Fracture or other significant injury to the tibia or humerus or surrounding musculature/tissue.
  • Inability to landmark IO placement due to excessive tissue over placement location.
  • Anticipated surgery within 12 hours of time of consent
  • Current infection at the placement site.
  • Previous, significant orthopedic procedure at the site
  • Pregnant or has the potential for being pregnant
  • Prisoner of the state
  • Minor (< 18 years old)
  • Inability to obtain informed consent from family member
  • Non-English speaking patient

结局指标

主要结局

Standardized Ratio as a Percentage Between Mean IOP and Mean Arterial Pressure

时间窗: Up to 12 hour data collection period

External cuff pressure readings were recorded every 15 minutes, and IO pressure data obtained via pressure transducer was recorded continuously for up to 12 hours. IO systolic, diastolic, and mean pressure (IO SBP, IO DBP, IO Mean) readings were summarized for the minute before and minute following an external cuff pressure reading. The ratios as a percentage of IO pressures to external cuff pressures (IO Systolic Blood Pressure / Cuff SBP; IO DBP / Cuff DBP; IO Mean / Cuff Mean) were calculated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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