CLE and OCT in Acute Respiratory Insufficiency (CLEOPATRA)

Confocal Laser Endomicroscopy and Optical Coherence Tomography in Acute Respiratory Insufficiency

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.

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Failure (Non Resolving)
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Kirsten Kalverda, MD; Phone Number: +31205664356; Email: k.a.kalverda@amsterdamumc.nl
• Study Contact Backup: Name: Lizzy Wijmans, MD; Email: l.wijmans@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • Recruiting
      • Academisch Medisch Centrum
      • Principal Investigator: Marcus J Schultz, MD, PHD
      • Contact: Kirsten Kalverda, MD; Phone Number: +31205664356; Email: k.a.kalverda@amsterdamumc.nl
      • Principal Investigator: Jouke T Annema, MD, PhD
      • Sub-Investigator: Lizzy Wijmans, MD
      • Sub-Investigator: Lieuwe Bos, MD, PhD
      • Sub-Investigator: Peter I Bonta, MD, PhD
      • Sub-Investigator: Kirsten Kalverda, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Anticipated): August 11, 2020
• Study Completion (Anticipated): August 11, 2020

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Optical coherence Tomography; Confocal Laser Endomicroscopy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: NL61112.018.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We plan to share the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No