CLE and OCT in Acute Respiratory Insufficiency

NCT ID: NCT04479007

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-11

Study Completion Date

2020-08-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Respiratory Failure (Non Resolving)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Probe based optical techniques

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof J.T. Annema

Head of department of pulmonal endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jouke T Annema, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Marcus J Schultz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Academisch Medisch Centrum

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kirsten Kalverda, MD

Role: CONTACT

+31205664356

Lizzy Wijmans, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kirsten Kalverda, MD

Role: primary

+31205664356

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NL61112.018.17

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ARDS Caused by COVID-19
NCT04368975 UNKNOWN