ARDS, HumanNCT03309085
Functional Respiratory Imaging of Airways in ARDS
A study testing Repeated CT scan and CT scan in people with ARDS, Human, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
This is a prospective single-center cohort trial to compare regional bronchial recruitment, bronchial distention and alveolar recruitment in 6 patients with acute respiratory distress syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human
- What is being tested?
- Repeated CT scan and CT scan
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Aug 2013to 14 Apr 2014
- Phase
- Interventional
- 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
Who may be able to join
- mechanically ventilated
- moderate or severe ARDS, as defined by the Berlin criteria
Who cannot join
- pregnancy
- hemodynamic instability
- obesity (BMI >30)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Imaging With Computational Fluid Dynamics to Evaluate the Airways in Patients With Acute Lung Injury
This is a prospective single-center cohort trial to compare regional bronchial recruitment, bronchial distention and alveolar recruitment in 6 patients with acute respiratory distress syndrome (ARDS). The investigators used CT scan images as the imaging modality, and the subjects were scanned on end-expiratory lung volume with different positive end-expiratory pressures. Those images were post-processed to evaluate the airways.
- Conditions
- ARDS, Human
- Being tested
- Repeated CT scan, CT scan
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated CT scanProcedure or surgery
CT scan of chest on different PEEP levels, 4 in total
CT scanDevice
CT scan
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Repeated CT scan Receives: Procedure: Repeated CT scan; Device: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional bronchial recruitment
The difference in bronchial tree volume increase from one PEEP level to the other
Measured: Through study completion, within 24 hours after inclusion
Regional bronchial dilation
The difference in bronchial diameter from one PEEP level to the other
Measured: Through study completion, within 24 hours after inclusion
Regional alveolar recruitment
The difference in alveolar volume from one PEEP level to the other
Measured: Through study completion, within 24 hours after inclusion
Secondary outcomes (1)
Correlation between parenchymal recruitment and bronchial recruitment
Correlation between parenchymal recruitment (in milliliter) and bronchial (in milliliter) recruitment for each type of ARDS (focal versus diffuse)
Measured: Through study completion, within 24 hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start13 Aug 2013
- Primary completion14 Apr 2014
- Study completion14 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Schepens, MD, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309085
- Sponsor's protocol ID
- EC 10/52/359
- Other IDs
- B300201010195
- Status last verified
- Oct 2017
- First submitted
- 3 Oct 2017
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Imaging With Computational Fluid Dynamics to Evaluate the Airways in Patients With Acute Lung Injury
- ClinicalTrials.gov ID
- NCT03309085
- Acronym / sponsor ID
- EC 10/52/359
- Conditions
- ARDS, Human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 13 Aug 2013 (actual)
- Primary completion
- 14 Apr 2014 (actual)
- Study completion
- 14 Apr 2014 (actual)
- First posted
- 13 Oct 2017 (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.
This is a prospective single-center cohort trial to compare regional bronchial recruitment, bronchial distention and alveolar recruitment in 6 patients with acute respiratory distress syndrome (ARDS). The investigators used CT scan images as the imaging modality, and the subjects were scanned on end-expiratory lung volume with different positive end-expiratory pressures. Those images were post-processed to evaluate the airways.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Procedure: Repeated CT scan, Device: CT scanRepeated CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mechanically ventilated
- moderate or severe ARDS, as defined by the Berlin criteria
Key exclusion criteria (3 listed)
- pregnancy
- hemodynamic instability
- obesity (BMI >30)
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 |
|---|---|---|
| Repeated CT scanCT scan of chest on different PEEP levels, 4 in total | Procedure or surgery | Single arm |
| CT scanCT scan | Device | Single arm |
Primary outcome
Regional bronchial recruitment
Time frame: Through study completion, within 24 hours after inclusion
The difference in bronchial tree volume increase from one PEEP level to the other
Regional bronchial dilation
Time frame: Through study completion, within 24 hours after inclusion
The difference in bronchial diameter from one PEEP level to the other
Regional alveolar recruitment
Time frame: Through study completion, within 24 hours after inclusion
The difference in alveolar volume from one PEEP level to the other
1 secondary outcome
Correlation between parenchymal recruitment and bronchial recruitment
Time frame: Through study completion, within 24 hours after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repeated CT scan and CT scan in people with ARDS, Human, run by University Hospital, Antwerp at 1 site in Belgium.
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 3 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: finished, as of the sponsor's last update on 13 Oct 2017. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional bronchial recruitment (time frame: Through study completion, within 24 hours after inclusion). The study lists 3 primary outcomes in all. 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 13 Oct 2017.