Acute Respiratory Distress Syndrome (ARDS)NCT01926093
Low Dose Lung CT Scan for Quantitative Analysis in ARDS Patients
An observational study of Acute Respiratory Distress Syndrome (ARDS), run by Policlinico Hospital at 1 site in Italy.
Trial summary
We aimed to assess the accuracy of visual and quantitative analysis performed on low radiation dose lung CT scan (30-60 mAs)compared with that performed on standard radiation dose lung CT scan (110 mAs), in ARDS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2012to May 2013
- 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: ARDS patients fulfilling the Berlin definition criteria
Who may be able to join
- Acute Respiratory Distress Syndrome
- CT scan performed for clinical purposes
Who cannot join
- Age < 18 years
- hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
We aimed to assess the accuracy of visual and quantitative analysis performed on low radiation dose lung CT scan (30-60 mAs)compared with that performed on standard radiation dose lung CT scan (110 mAs), in ARDS patients. If the results in computing lung recruitment will be similar, we will be able to use Low Dose CT scan for monitoring of the evolution of the disease in ARDS patients.
- Keywords
- Acute Respiratory Distress Syndrome (ARDS)
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between Standard and Low Dose lung CT scan in visual and quantitative analysis
We measured lung recruitment with visual and quantitative analysis both on standard and low dose CT scan.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startJun 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Chiumello, Policlinico Hospital
- Investigators
- Davide Chiumello, MD, Principal investigator, IRCCS Ca' Granda - Ospedale MAggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926093
- Sponsor's protocol ID
- Policlinico-08
- Other IDs
- 3102-28/12/2012
- Status last verified
- Aug 2013
- First submitted
- 13 Aug 2013
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Lung CT Scan for Quantitative Analysis in ARDS Patients
- ClinicalTrials.gov ID
- NCT01926093
- Acronym / sponsor ID
- Policlinico-08
- Keywords
- Acute Respiratory Distress Syndrome (ARDS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Aug 2013 (estimated)
- 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.
We aimed to assess the accuracy of visual and quantitative analysis performed on low radiation dose lung CT scan (30-60 mAs)compared with that performed on standard radiation dose lung CT scan (110 mAs), in ARDS patients. If the results in computing lung recruitment will be similar, we will be able to use Low Dose CT scan for monitoring of the evolution of the disease in ARDS patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ARDS patients fulfilling the Berlin definition criteria
Key inclusion criteria (2 listed)
- Acute Respiratory Distress Syndrome
- CT scan performed for clinical purposes
Key exclusion criteria (2 listed)
- Age < 18 years
- hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference between Standard and Low Dose lung CT scan in visual and quantitative analysis
Time frame: 1 day
We measured lung recruitment with visual and quantitative analysis both on standard and low dose CT scan.
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 9 Jan 2014.
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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.
Davide Chiumello, MD principal investigator
IRCCS Ca' Granda - Ospedale MAggiore Policlinico
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 Distress Syndrome (ARDS), run by Policlinico Hospital at 1 site in Italy.
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: finished, as of the sponsor's last update on 9 Jan 2014. 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 Italy. 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?
Difference between Standard and Low Dose lung CT scan in visual and quantitative analysis (time frame: 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 9 Jan 2014; AzTrials last refreshed its copy on 2 Nov 2026.