EUCTR2015-005676-25-GB
Active, Not Recruiting
Phase 1
Sensing using Neutrophil Activation Probe on the Intensive Therapy Unit - Sensing using Neutrophil Activation Probe on IT
niversity of Edinburgh0 sites75 target enrollmentMay 23, 2018
ConditionsCritical illness requiring ventilationMedDRA version: 20.0Level: PTClassification code 10077264Term: Critical illnessSystem Organ Class: 10018065 - General disorders and administration site conditionsMedDRA version: 20.0Level: LLTClassification code 10003541Term: Assisted ventilationSystem Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Critical illness requiring ventilation
- Sponsor
- niversity of Edinburgh
- Enrollment
- 75
- Status
- Active, Not Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\)
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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