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临床试验/NCT05817968
NCT05817968已完成不适用

Comparison of a Solid State Versus Balloon Esophageal Catheter for Estimation of Pleural Pressure in Surgical ICU Patients

Erasmus Medical Center2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2023年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Difference in absolute Pes-derived parameters obtained by solid state catheter vs. balloon catheter.

研究概览

简要总结

Measurements of esophageal pressure (Pes) as surrogate for pleural pressure are routinely performed in selected ICU patients to facilitate lung-protective ventilation and assess breathing effort. Pes is clinically measured via a nasogastric esophageal catheter. Current techniques involve balloon catheters but have some important disadvantages as they could deflate over time and require a very precise positioning and filling volume. A solid-state sensor does not have disadvantages associated with balloon catheters and may therefore be a useful alternative in clinical practice.

This method-comparison study in adult mechanically ventilated ICU patients evaluates the accuracy of Pes measured using an esophageal catheter with a solid-state sensor as compared to a balloon catheter as reference standard.

详细描述

Measurements of esophageal pressure (Pes) as surrogate for pleural pressure are routinely performed in selected ICU patients to facilitate lung-protective ventilation and assess breathing effort. Pes is clinically measured via a nasogastric esophageal catheter. Current techniques involve balloon catheters but have some important disadvantages as they could deflate over time and require a very precise positioning and filling volume. A solid state sensor does not have disadvantages associated with balloon catheters and may therefore be a useful alternative in clinical practice.

This method-comparison study in adult mechanically ventilated ICU patients evaluates the accuracy of Pes measured using an esophageal catheter with a solid-state sensor as compared to a balloon catheter as reference standard.

Subjects will receive a standard balloon esophageal catheter and a solid-state pressure catheter for simultaneous measurements of Pes. Study population will be post-surgical ICU patients. Measurements will be performed during clinical mechanical ventilation settings which include a first phase of passive controlled ventilation (patient is still sedated after surgery) as well a phase of partially-assisted ventilation where the patient's breathing effort has resumed and is assisted by the ventilator. During both phases, 10-15 minutes of tidal breathing will be recorded.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Signed informed consent
  • Patient requiring mechanical ventilation at the ICU following cardiothoracic or abdominal surgery
  • Age ≥ 18 year

排除标准

  • Pregnancy
  • Upper airway/esophageal/mouth or face pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia)
  • Nasal bleeding within the last <2 weeks
  • Presence of pneumothorax
  • Use of anticoagulants that increase the risk of catheter insertion

结局指标

主要结局

Difference in absolute Pes-derived parameters obtained by solid state catheter vs. balloon catheter.

时间窗: 30 minutes

Absolute Pes value (in cmH2O) at end-expiration and at peak inspiration (based on flow recordings) will be recorded.

Difference in relative Pes-derived parameters obtained by solid state catheter vs. balloon catheter.

时间窗: 30 minutes

Relative Pes value (cmH2O) will be measured as the inspiratory amplitude in Pes.

次要结局

未报告次要终点

研究者

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

Annemijn Jonkman

Assistant Professor

Erasmus Medical Center

研究点 (2)

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