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Sensing Using Neutrophil Activation Probe on the Intensive Therapy Unit (SNAP-IT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804854
Recruitment Status : Unknown
Verified December 2016 by University of Edinburgh.
Recruitment status was:  Recruiting
First Posted : June 17, 2016
Last Update Posted : May 5, 2017
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
University of Edinburgh

Tracking Information
First Submitted Date  ICMJE June 2, 2016
First Posted Date  ICMJE June 17, 2016
Last Update Posted Date May 5, 2017
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • Reproducibility of NAP signal [ Time Frame: Length of the study - two years ]
    The reliability of the NAP/FE procedure as determined by the reproducibility of NAP signal during multiple transbronchial passes of the same segment in the same patient, averaged over the entire enrolled population.
  • Discriminant ability of NAP signal in normal or abnormal lung segments [ Time Frame: Length of the study - two years ]
    The accuracy of the NAP/FE procedure as determined by the discriminant ability of NAP signal in normal or abnormal lung segments, where the reference standard is contemporaneous clinician interpretation of available radiology at the time of study procedure.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02804854 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sensing Using Neutrophil Activation Probe on the Intensive Therapy Unit
Official Title  ICMJE Sensing Using Neutrophil Activation Probe on the Intensive Therapy Unit
Brief Summary Critically ill patients often succumb to acute respiratory disease (rapidly developing disease affecting the lungs). The lungs are the commonest organ to fail and require support in the intensive care environment. However, no accurate methods exist that can be used at the bedside to tell what is causing deterioration in a person's lungs. There are various examples of acute respiratory diseases that can occur as a result of numerous different causes, have a high risk of death and cannot be treated easily with drugs. When trying to accurately diagnose and classify these lung diseases there is a risk that the type of respiratory disease is misdiagnosed, missed or the level of severity is not captured. By using the field of optical molecular imaging and employing novel techniques and technologies, the investigators hope to demonstrate here that a bespoke chemical probe administered in micro doses (tiny doses) directly into the distal lung can rapidly and accurately detect activated neutrophils (cells of the immune system that are implicated in the development of these severe conditions), and so work towards a bedside test which could be used to diagnose, monitor and classify the disease in patients who are critically ill in the future. The population for this study are in intensive care where patients are normally intubated (have a breathing tube) due to the severity of their illness, this may be because of respiratory problems or respiratory problems can rapidly develop. Participants will have the chemical probe administered into their lungs and pictures taken through the tube already in place. As this probe lights up when it comes into contact with neutrophils the investigators will be able to tell if neutrophils are present. This will inform a larger study in which it's hoped that the method can be used to inform clinical decisions. The first procedure will take place within two days of initiation of mechanical ventilation and the direct contact with the study team will be completed within nine days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Lung Disease
Intervention  ICMJE Drug: Neutrophil Activation Probe (NAP)
Delivery of NAP by direct pulmonary administration followed by fibreoptic confocal microendoscopy. A total of 240 mcg (±25%) in three divided doses of 80 mcg (±25%).
Study Arms  ICMJE Experimental: Patients in ICU
Delivery of Neutrophil Activation Probe (NAP) (80mcgs) to ventilated patients up to three times.
Intervention: Drug: Neutrophil Activation Probe (NAP)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2018
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

    o Absence of pulmonary infiltrates on the aforementioned chest radiological imaging

  • ABNORMAL BAL (n=5)

    • Pulmonary infiltrate on chest radiological imaging
    • Suspicion of community acquired pneumonia or ventilator associated pneumonia as determined by the clinical care team.

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02804854
Other Study ID Numbers  ICMJE AC16025
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Edinburgh
Study Sponsor  ICMJE University of Edinburgh
Collaborators  ICMJE Medical Research Council
Investigators  ICMJE
Study Director: Kev Dhaliwal, MRCP PhD University of Edinburgh
PRS Account University of Edinburgh
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP