CLEOPATRA: CLE and OCT in Acute Respiratory Insufficiency

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)

Overall Status

Unknown status

CT.gov ID

NCT04479007

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure (Non Resolving)	Device: Probe based optical techniques

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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Confocal Laser Endomicroscopy and Optical Coherence Tomography in Acute Respiratory Insufficiency

Actual Study Start Date :

Oct 11, 2017

Anticipated Primary Completion Date :

Aug 11, 2020

Anticipated Study Completion Date :

Aug 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Mechanically ventilated patients 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.	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).

Arm

Intervention/Treatment

Mechanically ventilated patients

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.

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).

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Academisch Medisch Centrum	Amsterdam	Noord-Holland	Netherlands	1105 AZ

Sponsors and Collaborators

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

Investigators

Principal Investigator: Jouke T Annema, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Marcus J Schultz, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof J.T. Annema, Head of department of pulmonal endoscopy, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

ClinicalTrials.gov Identifier:

NCT04479007

Other Study ID Numbers:

NL61112.018.17

First Posted:

Jul 21, 2020

Last Update Posted:

Jul 21, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Prof J.T. Annema, Head of department of pulmonal endoscopy, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Confocal Laser Endomicroscopy

Optical coherence Tomography

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of Jul 21, 2020