Sensing using Neutrophil Activation Probe on the Intensive Therapy Unit

Phase 1

• Conditions: Critical illness requiring ventilation; MedDRA version: 20.0Level: LLTClassification code 10003541Term: Assisted ventilationSystem Organ Class: 100000004865; MedDRA version: 20.0Level: PTClassification code 10077264Term: Critical illnessSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2015-005676-25-GB
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-23
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

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)
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

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
•Pregnancy

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified