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CLE and OCT in Acute Respiratory Insufficiency (CLEOPATRA)

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ClinicalTrials.gov Identifier: NCT04479007
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
Prof J.T. Annema, 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.

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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 : October 11, 2017
Estimated Primary Completion Date : August 11, 2020
Estimated Study Completion Date : August 11, 2020

Resource links provided by the National Library of Medicine


Group/Cohort 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).




Primary Outcome Measures :
  1. Technical feasibility of various (diseased/non-diseased on HRCT-scan) alveolar compartments in mechanically ventilated patients [ Time Frame: coss sectional (1 day) ]
    Percentage of successful imaging


Secondary Outcome Measures :
  1. Comparison of pCLE/OCT to radiological patterns [ Time Frame: cross sectional (1 day) ]
    Degree of similarity pCLE/OCT-imaging compared to HRCT

  2. Comparison of pCLE/OCT with pathology [ Time Frame: cross sectional (1 day) ]
    Degree of similarity between pCLE/OCT characteristics with pathology (in case available)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mechanically ventilated patients mandating a procedure that includes inspection of the airways and can be combined with pCLE/OCT. Patients can only be included when the research physician decides they are eligible. (based on the heterogeneity of the disease and the suspected etiology).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04479007


Contacts
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Contact: Kirsten Kalverda, MD +31205664356 k.a.kalverda@amsterdamumc.nl
Contact: Lizzy Wijmans, MD l.wijmans@amsterdamumc.nl

Locations
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Netherlands
Academisch Medisch Centrum Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Kirsten Kalverda, MD    +31205664356    k.a.kalverda@amsterdamumc.nl   
Principal Investigator: Jouke T Annema, MD, PhD         
Sub-Investigator: Lizzy Wijmans, MD         
Principal Investigator: Marcus J Schultz, MD, PhD         
Sub-Investigator: Lieuwe Bos, MD, PhD         
Sub-Investigator: Peter I Bonta, MD, PhD         
Sub-Investigator: Kirsten Kalverda, MD         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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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)
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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: July 21, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We plan to share the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Confocal Laser Endomicroscopy
Optical coherence Tomography
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases