CLE and OCT in Acute Respiratory Insufficiency

Acute Respiratory Failure (Non Resolving) Clinical Trial

— CLEOPATRA  

Official title:

Confocal Laser Endomicroscopy and Optical Coherence Tomography in Acute Respiratory Insufficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04479007
• Other study ID #: NL61112.018.17
• Status: Recruiting
• Start date: October 11, 2017
• Est. completion date: August 11, 2020

Study information

• Verified date: July 2020
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Kirsten Kalverda, MD
• Phone: +31205664356
• Email: k.a.kalverda[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 11, 2020
• Est. primary completion date: August 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure (Non Resolving)
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Netherlands	Academisch Medisch Centrum	Amsterdam	Noord-Holland

Sponsors (1)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical feasibility of various (diseased/non-diseased on HRCT-scan) alveolar compartments in mechanically ventilated patients	Percentage of successful imaging	coss sectional (1 day)
Secondary	Comparison of pCLE/OCT to radiological patterns	Degree of similarity pCLE/OCT-imaging compared to HRCT	cross sectional (1 day)
Secondary	Comparison of pCLE/OCT with pathology	Degree of similarity between pCLE/OCT characteristics with pathology (in case available)	cross sectional (1 day)