Sensing Using Neutrophil Activation Probe on the Intensive Therapy Unit

NCT ID: NCT02804854

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2022-07-31

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.

Conditions

Lung Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients in ICU

Delivery of Neutrophil Activation Probe (NAP) (80mcgs) to ventilated patients up to three times.

Group Type: EXPERIMENTAL

Neutrophil Activation Probe (NAP)

Intervention Type: DRUG

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%).

Interventions

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%).

Intervention Type: DRUG

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.

Exclusion Criteria

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.

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kev Dhaliwal, MRCP PhD

Role: STUDY_DIRECTOR

University of Edinburgh

Locations

Ward 118 Intensive Care, Royal Infirmary of Edinburgh

Edinburgh, Edinburgh City, United Kingdom

Western General Hospital

Edinburgh, Edinburgh City, United Kingdom

Countries

United Kingdom

Other Identifiers

AC16025

Identifier Type: -

Identifier Source: org_study_id