To identify the characteristics on CLE images of the alveolar compartment in mechanically ventilated COVID19 patients with non-resolving acute respiratory failure.
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
identification of specific CLE patterns of the alveolar compartment of COVID 19
invasivally ventilated patients
Secondary outcome
-Description of how CLE patterns change over time within the same patients
- Descriptive correlation of CLE patterns with Chest CT
- Descriptive correlation of CLE patterns with lung ultrasound
- Descriptive correlation of CLE patterns with cytology from bronchoalveolar
lavage
-Descriptive correlation of in vivo CLE patterns with histology (when available)
-Descriptive correlation of ex vivo CLE images with histology (when available)
-Time of procedure
- Proportion of successful imaging of alveolar compartment
Background summary
Acute respiratory distress syndrome (ARDS) is an infrequent but severe
complication of COVID 19. The clinical syndrome of ARDS form a heterogeneous
group of patients with varying underlying pathophysiology, of which some
develop pulmonary fibrosis. COVID 19 patients with ARDS might even be more
prone to developing fibrosis due to prolonged need for mechanical ventilation.
Identification of patients with fibrotic changes in an early stage might
influence therapeutic management, but is challenging using current diagnostics.
The innovative probe-based imaging techniques *Confocal Laser
Endomicroscopy* (CLE) is a high-resolution optical technique that, combined
with conventional bronchoscopy, has been found to provide real-time,
near-histology information about the alveolar compartment in both
non-ventilated and (intubated) critically ill patients.
Study objective
To identify the characteristics on CLE images of the alveolar compartment in
mechanically ventilated COVID19 patients with non-resolving acute respiratory
failure.
Study design
investigator-initiated, observational study in 15 mechanically ventilated
critically ill patients with non-resolving acute respiratory failure.
Study burden and risks
Patients in this study will not benefit from participation. There is little to
no burden related to study participation. Bronchoscopy with bronchoalveolar
lavage (BAL) is part of the standard diagnostic clinical care. For study
purposes, the clinically indicated bronchoscopy with be combined with CLE
imaging in the same session. This lengthens the standard procedure with 2 to 4
minutes. Since ICU patients are sedated as a part of standard ICU care,
patients will be unaware of the CLE imaging. Adverse events are not expected
based on our own CLE experience in ARDS patients and interstitial lung disease
(ILD) patients which is in concordance with the literature, where bronchoscopy
combined with probe-based optical techniques in non-ventilated patients was
reported to be safe, easy to perform and little time-consuming, without adverse
events. In conclusion, in our opinion the burden and risks associated with the
additional probe based optical technique measurements are negligible.
Meibergdreef 9
Amsterdam 1100 DD
NL
Meibergdreef 9
Amsterdam 1100 DD
NL
Listed location countries
Age
Inclusion criteria
- *18 years of age
- Non-resolving acute respiratory failure mandating a standard
diagnostic bronchoscopy with broncho-alveolar lavage
Exclusion criteria
- Inability and willingness to provide informed consent by family-members
-ECMO
- Inability to comply with the study protocol
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76007.018.20 |