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临床试验/NCT06868810
NCT06868810已完成不适用

Comparison of 5% Sodium Bicarbonate and 10% Sodium Chloride As Contrast Agents for Lung Perfusion with Electrical Impedance Tomography: a Prospective Clinical Study

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
lung perfusion distribution in ROI

研究概览

简要总结

Electrical impedance tomography (EIT) has enabled the bedside monitoring of lung perfusion measurement through the indicator-based contrast method. Currently, hypertonic sodium chloride is the most commonly used contrast agent for lung perfusion evaluation by EIT. However, concerns may be raised regarding the potential risks of hyperchloremia and possible acute kidney injury associated with the use of hypertonic NaCl. Recently, two experimental studies found sodium bicarbonate (NaHCO3) might be an alternative to hypertonic sodium chloride in lung perfusion assessment by EIT. However, whether NaHCO3 results in acceptable bias is unknown in critically ill patients. This clinical study aimed to further investigate the correlation and agreement of lung perfusion and Ventilation/perfusion (V/Q) match by EIT contrast method between two contrast indicators (5%NaHCO3 vs. 10% NaCl) in critically ill patients with respiratory failure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •In need of lung perfusion assessment due to clinical condition
  • •With central venous catheter

排除标准

  • •contraindications to the use of EIT (automatic implantable cardioverter defibrillator, chest wounds limiting electrode belt placement, implantable pumps, etc.)
  • •severe hyperchloremia (>155 mmol/L)
  • •unable to tolerate breath-hold maneuver
  • •pregnant or breastfeeding females

研究组 & 干预措施

NaCl

Experimental

First, perform the EIT contrast method with 10% NaCl. After a 10-minute washout period, perform the EIT contrast method with 5% NaHCO3.

干预措施: Injection of hypertonic saline (Other)

NaCl

Experimental

First, perform the EIT contrast method with 10% NaCl. After a 10-minute washout period, perform the EIT contrast method with 5% NaHCO3.

干预措施: Injection of 5% NaHCO3 (Other)

NaHCO3

Other

First, perform the EIT contrast method with 5% NaHCO3. After a 10-minute washout period, perform the EIT contrast method with 10% NaCl.

干预措施: Injection of hypertonic saline (Other)

NaHCO3

Other

First, perform the EIT contrast method with 5% NaHCO3. After a 10-minute washout period, perform the EIT contrast method with 10% NaCl.

干预措施: Injection of 5% NaHCO3 (Other)

结局指标

主要结局

lung perfusion distribution in ROI

时间窗: Offline analysis, immediately after the saline injection procedure

次要结局

  • V/Q match in ROI(Offline analysis, immediately after the saline injection procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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