CLE and OCT in Acute Respiratory Insufficiency

NCT04479007 | Unknown DMC

• 1 other identifier: NL61112.018.17
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure (Non Resolving)

Keywords

Confocal Laser Endomicroscopy; Optical coherence Tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of pCLE/OCT to radiological patterns

  cross sectional (1 day)

• Comparison of pCLE/OCT with pathology

  cross sectional (1 day)

Study Arms (1)

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

Interventions

Probe based optical techniques DEVICE

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

Mechanically ventilated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• Inability and willingness to provide informed consent by family-members
• Inability to comply with the study protocol

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academisch Medisch Centrum

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten Kalverda, MD

CONTACT

+31205664356; k.a.kalverda@amsterdamumc.nl

Lizzy Wijmans, MD

CONTACT

l.wijmans@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of pulmonal endoscopy

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: July 21, 2020
• Study Start: October 11, 2017
• Primary Completion: August 11, 2020
• Study Completion: August 11, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

NL (1)