Acute Respiratory Distress SyndromeNCT00682942
How to Predict Lung Recruitment at the Bedside in Patients Affected by Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS)
An observational study of Acute Respiratory Distress Syndrome, run by Policlinico Hospital at 1 site in Italy.
Trial summary
The investigators aim to compare four different lung recruitment techniques (described in literature) to Computed tomography scan analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- May 2008to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients affected by acute lung injury/acute respiratory distress syndrome who are mechanically ventilated
Who may be able to join
- Clinical diagnosis of acute lung injury/ acute respiratory distress syndrome
- Mechanical ventilation
Who cannot join
- Clinical diagnosis of chronic obstructive pulmonary disease
- Clinical diagnosis of pneumothorax
- Haemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to compare four different lung recruitment techniques (described in literature) to Computed tomography scan analysis.
Read the detailed description
The investigators aim to compare four different lung recruitment techniques (described in literature) to Computed tomography scan analysis:
- stress index technique
- peep test
- recruitment technique used in the EXPRESS study
- recruitment technique used in the LOV study
- Conditions
- Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- 50 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, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682942
- Sponsor's protocol ID
- 16500
- Status last verified
- Nov 2011
- First submitted
- 21 May 2008
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Predict Lung Recruitment at the Bedside in Patients Affected by Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS)
- ClinicalTrials.gov ID
- NCT00682942
- Acronym / sponsor ID
- 16500
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 May 2008 (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 investigators aim to compare four different lung recruitment techniques (described in literature) to Computed tomography scan analysis.
Detailed description
The investigators aim to compare four different lung recruitment techniques (described in literature) to Computed tomography scan analysis:
- stress index technique
- peep test
- recruitment technique used in the EXPRESS study
- recruitment technique used in the LOV study
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
- patients affected by acute lung injury/acute respiratory distress syndrome who are mechanically ventilated
Key inclusion criteria (2 listed)
- Clinical diagnosis of acute lung injury/ acute respiratory distress syndrome
- Mechanical ventilation
Key exclusion criteria (3 listed)
- Clinical diagnosis of chronic obstructive pulmonary disease
- Clinical diagnosis of pneumothorax
- Haemodynamic 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
Not reported in the source record.
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 1 Dec 2011.
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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
Policlinico Hospital
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, 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 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 1 Dec 2011. 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.
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 1 Dec 2011.