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临床试验/EUCTR2015-005676-25-GB
EUCTR2015-005676-25-GB进行中(未招募)1 期

Sensing using Neutrophil Activation Probe on the Intensive Therapy Unit - Sensing using Neutrophil Activation Probe on IT

niversity of Edinburgh0 个研究点目标入组 75 人开始时间: 2018年5月23日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
75

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • For all participants:
  • Participants aged 16 years or over
  • Participants who are predicted to require intubation for more than two calendar days, with this assessment made by a clinician (Registrar or Consultant in Intensive Care) who is independent of the study team.
  • Participants who have undergone chest radiological imaging within the preceding 48 hours prior to enrolment.
  • Participants who can undergo study bronchoscopy within the initial time period (C.D. 0-2) of first intubation in their present hospital admission (as determined by the absence of exclusion criteria for bronchoscopy laid out below).
  • For BAL subset (up to a total of 10 participants)
  • Permission given to undertake a BAL by independent attending consultant
  • CONTROL BAL (n=5)
  • oAbsence of pulmonary infiltrates on the aforementioned chest radiological imaging
  • ABNORMAL BAL (n=5)
  • oPulmonary infiltrate on chest radiological imaging
  • oSuspicion of community acquired pneumonia or ventilator associated pneumonia as determined by the clinical care team.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 5
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 40
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 30

排除标准

  • For enrolment into the study
  • Absence of consent from the participant or their personal or professional legal representative
  • Documented history of allergy to fluorescein
  • Prior to each bronchoscopy (as assessed within 24 hours of the start of the procedure)
  • Investigator not available to perform bronchoscopy with NAP/FE within the pre-specified time
  • Treatment withdrawal documented to take place within the next 24 hours
  • Presence of pneumothorax or intercostal chest drain
  • Refusal by the patient’s attending intensive care consultant
  • Prior to each study blood sampling
  • Haemoglobin (Hb) < 6.5 g/dL.
  • Prior to each BAL
  • Refusal to permit BAL by the participants attending consultant

研究者

发起方
niversity of Edinburgh

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