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CLE and OCT in Acute Respiratory Insufficiency

Confocal Laser Endomicroscopy and Optical Coherence Tomography in Acute Respiratory Insufficiency

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04479007
Acronym
CLEOPATRA
Enrollment
20
Registered
2020-07-21
Start date
2017-10-11
Completion date
2020-08-11
Last updated
2020-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure (Non Resolving)

Keywords

Confocal Laser Endomicroscopy, Optical coherence Tomography

Brief summary

Acute respiratory distress syndrome is a severe complication of critical illness. The diagnosis of ARDS is difficult, and it could be important to differentiate ARDS from other causes of acute respiratory failure. Innovative probe-based imaging techniques such as 'Confocal Laser Endomicroscopy' (CLE) and Optical Coherence Tomography (OCT) are high resolution optical techniques that, combined with conventional bronchoscopy, have been found to provide non-invasive, real-time near-histology information about the alveolar compartment in non ventilated non-critically ill patients.

Detailed description

It is important to identify the underlying cause of respiratory failure, in order to determine the appropriate treatment. Histopathology would help treatment decisions, however is in the fast majority of this critically ill patient-group not available. CLE is enables near histology/microscopic analysis during bronchoscopy, by tissue illumination with a low-power laser. Optical Coherence Tomography is the optical equivalent of B-mode ultrasonography, that consists of a small rotating optical fibre. Both the CLE and OCT techniques are minimally invasive and little time consuming. Therefore different areas of the lung can be sequentially imaged. With this pilot study the investigators aim to describe normal alveolar areas and areas with abnormalities in critically ill patients with non resolving acute respiratory failure mandating a standard bronchoscopy or laryngoscopy with or without bronchoalveolar lavage.

Interventions

During the intervention of inspecting the airways, different segments of the alveolar compartment will be imaged by two different probe based (CLE and OCT).

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Admitted to intensive care unit of academic medical center in Amsterdam * Indication for a procedure to investigate the airways that can be combined with pCLE/OCT

Exclusion criteria

* Inability and willingness to provide informed consent by family-members * Inability to comply with the study protocol

Design outcomes

Primary

MeasureTime frameDescription
Technical feasibility of various (diseased/non-diseased on HRCT-scan) alveolar compartments in mechanically ventilated patientscoss sectional (1 day)Percentage of successful imaging

Secondary

MeasureTime frameDescription
Comparison of pCLE/OCT to radiological patternscross sectional (1 day)Degree of similarity pCLE/OCT-imaging compared to HRCT
Comparison of pCLE/OCT with pathologycross sectional (1 day)Degree of similarity between pCLE/OCT characteristics with pathology (in case available)

Countries

Netherlands

Contacts

Primary ContactKirsten Kalverda, MD
k.a.kalverda@amsterdamumc.nl+31205664356
Backup ContactLizzy Wijmans, MD
l.wijmans@amsterdamumc.nl

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026