Acute Respiratory Failure (Non Resolving)CLEOPATRANCT04479007
CLE and OCT in Acute Respiratory Insufficiency
An observational study of Acute Respiratory Failure (Non Resolving), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure (Non Resolving)
- What is being tested?
- Probe based optical techniques
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Oct 2017to 11 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Inability and willingness to provide informed consent by family-members
- Inability to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
Lizzy Wijmans, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Academisch Medisch Centrum
Amsterdam, North Holland, 1105 AZ
Kirsten Kalverda, MD, +31205664356, k.a.kalverda@amsterdamumc.nl
Jouke T Annema, MD, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- Probe based optical techniques
- Keywords
- Confocal Laser Endomicroscopy, Optical coherence Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probe based optical techniquesDevice
During the intervention of inspecting the airways, different segments of the alveolar compartment will be imaged by two different probe based (CLE and OCT).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Probe based optical techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical feasibility of various (diseased/non-diseased on HRCT-scan) alveolar compartments in mechanically ventilated patients
Percentage of successful imaging
Measured: coss sectional (1 day)
Secondary outcomes (2)
Comparison of pCLE/OCT to radiological patterns
Degree of similarity pCLE/OCT-imaging compared to HRCT
Measured: cross sectional (1 day)
Comparison of pCLE/OCT with pathology
Degree of similarity between pCLE/OCT characteristics with pathology (in case available)
Measured: cross sectional (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start11 Oct 2017
- Primary completion11 Aug 2020 (estimated)
- Study completion11 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Failure (Non Resolving)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof J.T. Annema, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jouke T Annema, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Marcus J Schultz, MD, PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479007
- Sponsor's protocol ID
- NL61112.018.17
- Acronym
- CLEOPATRA
- Status last verified
- Jul 2020
- First submitted
- 25 Oct 2017
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share the data.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confocal Laser Endomicroscopy and Optical Coherence Tomography in Acute Respiratory Insufficiency
- ClinicalTrials.gov ID
- NCT04479007
- Acronym / sponsor ID
- CLEOPATRA / NL61112.018.17
- Keywords
- Confocal Laser Endomicroscopy, Optical coherence Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 11 Aug 2020 (estimated)
- Study completion
- 11 Aug 2020 (estimated)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanically ventilated patients | – | Device: Probe based optical techniquesCritically 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Inability and willingness to provide informed consent by family-members
- Inability to comply with the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probe based optical techniquesDuring the intervention of inspecting the airways, different segments of the alveolar compartment will be imaged by two different probe based (CLE and OCT). | Device | Mechanically ventilated patients |
Primary outcome
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
2 secondary outcomes
Comparison of pCLE/OCT to radiological patterns
Time frame: cross sectional (1 day)
Comparison of pCLE/OCT with pathology
Time frame: cross sectional (1 day)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: Undecided. We plan to share the data.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lizzy Wijmans, MD contact
Jouke T Annema, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Marcus J Schultz, MD, PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure (Non Resolving), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirsten Kalverda, MD (+31205664356, k.a.kalverda@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical feasibility of various (diseased/non-diseased on HRCT-scan) alveolar compartments in mechanically ventilated patients (time frame: coss sectional (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.