CLE and OCT in Acute Respiratory Insufficiency

• Conditions: Acute Respiratory Failure (Non Resolving)
• Interventions: Device: Probe based optical techniques

• Registration Number: NCT04479007
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study Start: 2017-10-11
• Study First Submitted: 2017-10-25
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-16
• Last Update Submitted: 2020-07-16
• Study First Posted: 2020-07-21
• Last Update Posted: 2020-07-21
• Primary Completion: 2020-08-11
• Study Completion: 2020-08-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mechanically ventilated patients	Probe based optical techniques	Critically ill patients of 18 years or older who receive invasive mechanical ventilation for acute respiratory failure and have an indication for an intervention in the airways.

Primary Outcome Measures

Name	Time	Method
Technical feasibility of various (diseased/non-diseased on HRCT-scan) alveolar compartments in mechanically ventilated patients	coss sectional (1 day)	Percentage of successful imaging

Secondary Outcome Measures

Name	Time	Method
Comparison of pCLE/OCT to radiological patterns	cross sectional (1 day)	Degree of similarity pCLE/OCT-imaging compared to HRCT
Comparison of pCLE/OCT with pathology	cross sectional (1 day)	Degree of similarity between pCLE/OCT characteristics with pathology (in case available)

Trial Locations

Locations (1)

Academisch Medisch Centrum; 🇳🇱 Amsterdam, Noord-Holland, Netherlands