跳至主要内容
临床试验/NCT04479007
NCT04479007Unknown不适用

Confocal Laser Endomicroscopy and Optical Coherence Tomography in Acute Respiratory Insufficiency

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年10月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Technical feasibility of various (diseased/non-diseased on HRCT-scan) alveolar compartments in mechanically ventilated patients

研究概览

简要总结

Acute respiratory distress syndrome is a severe complication of critical illness. The diagnosis of ARDS is difficult, and it could be important to differentiate ARDS from other causes of acute respiratory failure. Innovative probe-based imaging techniques such as 'Confocal Laser Endomicroscopy' (CLE) and Optical Coherence Tomography (OCT) are high resolution optical techniques that, combined with conventional bronchoscopy, have been found to provide non-invasive, real-time near-histology information about the alveolar compartment in non ventilated non-critically ill patients.

详细描述

It is important to identify the underlying cause of respiratory failure, in order to determine the appropriate treatment. Histopathology would help treatment decisions, however is in the fast majority of this critically ill patient-group not available. CLE is enables near histology/microscopic analysis during bronchoscopy, by tissue illumination with a low-power laser. Optical Coherence Tomography is the optical equivalent of B-mode ultrasonography, that consists of a small rotating optical fibre. Both the CLE and OCT techniques are minimally invasive and little time consuming. Therefore different areas of the lung can be sequentially imaged. With this pilot study the investigators aim to describe normal alveolar areas and areas with abnormalities in critically ill patients with non resolving acute respiratory failure mandating a standard bronchoscopy or laryngoscopy with or without bronchoalveolar lavage.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • Admitted to intensive care unit of academic medical center in Amsterdam
  • Indication for a procedure to investigate the airways that can be combined with pCLE/OCT

排除标准

  • Inability and willingness to provide informed consent by family-members
  • Inability to comply with the study protocol

结局指标

主要结局

Technical feasibility of various (diseased/non-diseased on HRCT-scan) alveolar compartments in mechanically ventilated patients

时间窗: coss sectional (1 day)

Percentage of successful imaging

次要结局

  • Comparison of pCLE/OCT to radiological patterns(cross sectional (1 day))
  • Comparison of pCLE/OCT with pathology(cross sectional (1 day))

研究者

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

Prof J.T. Annema

Head of department of pulmonal endoscopy

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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