Characterisation of pulmonary infiltrates in medically ventilated participants in the Intensive Care Unit Respiratory
Conditions
Interventions
As this is a non-randomised, early-stage medical device investigation, a control/placebo group has not been included.
Non-clinical interventions:
a) Informed consent, taken once per participant by a
Sponsors
The University of Edinburgh & Lothian Health Board ACCORD
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged =18 years 2. Informed consent provided by the participant or by a personal legal representative 3. Participant is receiving invasive ventilation (mechanically ventilated) 4. Participant has an abnormal CXR with suspected pulmonary infection 5. Deemed suitable for bronchoscopy and study procedures by the attending consultant 6. Readily accessible target areas with bronchoscopy and fibre-based endoscopy 7. Participant meets the criteria as set out in the co-enrolment section of the protocol
Exclusion criteria
Exclusion criteria: 1. Participant has a history of anaphylaxis and/or allergy to study SmartProbes (e.g. fluorescein) 2. Participant has a significant risk of bleeding (including any of the following: platelets at =50 x 109/L, therapeutic anticoagulation, APPTR >1.5, or INR >1.5) 3. Participant is a woman of childbearing potential and is pregnant and/or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety of devices will be measured/assessed by: 1.1. The number of adverse events that occur assessed at all timepoints from baseline up to and including 24-48 hours post bronchoscopy 1.2. Vital signs (haemodynamic observations) assessed at baseline, pre-bronchoscopy, 2-24 hours post-bronchoscopy, and 24-48 hours post-bronchoscopy 1.3. Oxygenation levels assessed during the bronchoscopy procedure 1.4. Chest X-ray (CXR) - any CXR or CT scan done clinically up to 48 hours before the bronchoscopy, and then taken again as a research-only procedure 2 hours (±1 hour) post bronchoscopy 2. Device performance will be measured/assessed by: 2.1. Demonstrating delivery of BACCOMBI into the alveolar space assessed by live imaging viewed at the time of the bronchoscopy (if live imaging available) and/or from imaging data recorded during bronchoscopy that is later reviewed and analysed 2.2. Demonstrating the capability of Eyes on Target (EoT) to collect sufficient distal Alveolar Lavage (AL) samples for PCR or other analyses (=100 µl), which is assessed by the volumes of samples collected and recorded during the bronchoscopy procedure 2.3. Demonstrating ability to visualise BACCOMBI in the alveolar space assessed by visualising the delivery of BACCOMBI at the time of the bronchoscopy (if live imaging available) and/or from imaging data recorded during bronchoscopy that is later reviewed and analysed | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quantification and characterisation of key inflammatory markers and inflammatory responses measured in BAL, AL, blood and ETA. This will be assessed after the samples are collected in either or both the NHS lab or the IRR research team labs 2. The range of micro-organisms characterised using nasopharyngeal swabs, BAL, ETA and/or AL assessed after samples are collected by the NHS lab 3. Antimicrobial susceptibility testing (AST) measured using up to two validated, quantitative molecular platforms in BAL assessed after samples are collected by NHS labs. 4. The performance of BACCOMBI (sensitivity, specificity, positive and negative predictive values) compared to three defined reference standards: 4.1. Constructed reference standard adjudicated by an expert clinical consensus panel for each participant using available clinical information. The adjudication will use all relevant data from microbiology, radiology, and clinical results collected at all timepoints of the study. The adjudication will occur after the participant's involvement has ended. 4.2. Semi-quantitative BAL culture (>104 colony-forming units/ml (cfu/ml) or equivalent). This will be assessed after the samples are collected by NHS labs. 4.3. Clinical Pulmonary Infection Score (CPIS) assessed at baseline. | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactJean Antonelli
Outcome results
None listed