ARDSNCT01881061
Lung Sonography in Patients With Acute Respiratory Distress Syndrome in Intensive Care Unit
An observational study of ARDS, run by University of Athens at 1 site in Greece.
Trial summary
The purpose of this study is to evaluate the role of lung sonography during different PEEP settings in ICU patients with ARDS. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ARDS
- How many people
- 10 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2009to Dec 2011
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU population
Who may be able to join
- Critically ill patients with ARDS admitted in ICU of Evangelismos Hospital
- length of stay > 48 hours
Who cannot join
- age < 18 years
- emphysema fractures or skin lesions that do not allow the implementation of lung sonography
- BMI > 35 kg/m2
- length of stay < 48 hours
Trial locations and contacts
1 site in 1 country.
Greece1 site
First Critical Care Unit, Evaggelismos Hospital, School of Medicine, University of Athens
Athens, Attica, 10676
About this study
The purpose of this study is to evaluate the role of lung sonography during different PEEP settings in ICU patients with ARDS.
Read the detailed description
Acute respiratory distress syndrome (ARDS) is a clinical syndrome that often occurs in critically ill patients.
Patients with ARDS invariably require mechanical ventilation to improve oxygen transport. An improvement in oxygenation can be obtained by an increase in positive end-expiratory pressure (PEEP).
In critically ill patients with ARDS, lung imaging is been held by the use of chest radiography and the "gold standard" technique, Computed Tomography (CT).
We designed an observational study in which we included patients under mechanical ventilation admitted in our ICU. In all patients PEEP changes were applied and lung sonography was performed.
- Conditions
- ARDS
- Keywords
- Sonography, ICU, PEEP
What is being measured
The primary outcome is the main question the study is designed to answer.
Non aerated lung area changes
Measured: 20 min after PEEP trial
Secondary outcomes (1)
Arterial oxygen and carbon dioxide partial pressure
Measured: 20 min after PEEP trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serafim Nanas, University of Athens
- Investigators
- Serafim Nanas, MD, Study chair, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881061
- Sponsor's protocol ID
- UOA-US-2010
- Status last verified
- Jun 2013
- First submitted
- 17 Jun 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Stefanidis K, Dimopoulos S, Tripodaki ES, Vitzilaios K, Politis P, Piperopoulos P, Nanas S. Lung sonography and recruitment in patients with early acute respiratory distress syndrome: a pilot study. Crit Care. 2011 Aug 4;15(4):R185. doi: 10.1186/cc10338.
PubMed 21816054
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Sonography in Patients With Acute Respiratory Distress Syndrome in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT01881061
- Acronym / sponsor ID
- UOA-US-2010
- Conditions
- ARDS
- Keywords
- Sonography, ICU, PEEP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Jun 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.
The purpose of this study is to evaluate the role of lung sonography during different PEEP settings in ICU patients with ARDS.
Detailed description
Acute respiratory distress syndrome (ARDS) is a clinical syndrome that often occurs in critically ill patients.
Patients with ARDS invariably require mechanical ventilation to improve oxygen transport. An improvement in oxygenation can be obtained by an increase in positive end-expiratory pressure (PEEP).
In critically ill patients with ARDS, lung imaging is been held by the use of chest radiography and the "gold standard" technique, Computed Tomography (CT).
We designed an observational study in which we included patients under mechanical ventilation admitted in our ICU. In all patients PEEP changes were applied and lung sonography was performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU population
Key inclusion criteria (2 listed)
- Critically ill patients with ARDS admitted in ICU of Evangelismos Hospital
- length of stay > 48 hours
Key exclusion criteria (4 listed)
- age < 18 years
- emphysema fractures or skin lesions that do not allow the implementation of lung sonography
- BMI > 35 kg/m2
- length of stay < 48 hours
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
Non aerated lung area changes
Time frame: 20 min after PEEP trial
1 secondary outcome
Arterial oxygen and carbon dioxide partial pressure
Time frame: 20 min after PEEP trial
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 19 Jun 2013.
- Results publication: PubMed 21816054Stefanidis K, Dimopoulos S, Tripodaki ES, Vitzilaios K, Politis P, Piperopoulos P, Nanas S. Lung sonography and recruitment in patients with early acute respiratory distress syndrome: a pilot study. Crit Care. 2011 Aug 4;15(4):R185. doi: 10.1186/cc10338.
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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.
Serafim Nanas, MD study chair
University of Athens
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 ARDS, run by University of Athens at 1 site in Greece.
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 4 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 19 Jun 2013. 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 Greece. 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?
Non aerated lung area changes (time frame: 20 min after PEEP trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01881061, which also lists 1 linked publication.
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 19 Jun 2013.