Acute Respiratory Distress SyndromeNCT00714987
The EVLW for Set the Positive End Expiratory Pressure (PEEP) in the Acute Respiratory Distress Syndrome (ARDS)
An observational study of Acute Respiratory Distress Syndrome, run by University Hospital, Strasbourg, France.
Trial summary
ARDS is a severe pathology with high mortality and morbidity.Actual ventilatory management is clear for the set of the tidal volume and for the survey of the plateau pressure for the patients who require mechanical ventilation. 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
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Feb 2009
- 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: All patients mechanically ventilated, monitored with the Picco® system, hospitalized in a medical critical care unit of an university hospital
Who may be able to join
- age>18;
- ARDS criteria.
Who cannot join
- severe pulmonary hypertension;
- chronic right ventricular failure;
- pulmonary embolism;
- tricuspidian valvulopathy;
- history of spontaneous pneumothorax;
- severe emphysema;
Show all 14Show fewer
- bronchomalacia;
- recent pulmonary surgery;
- BMI>40;
- Interstitial pulmonary fibrosis;
- End of life;
- Chronic neuromyopathie;
- Recent neurosurgery or intracranian hypertension;
- Pregnancy.
About this study
Official title: Predictive Value of the Extra-Vascular Lung Water (EVLW) for the Alveolar Recruitment in the Acute Respiratory Distress Syndrome ( ARDS ).
- ARDS is a severe pathology with high mortality and morbidity.Actual ventilatory management is clear for the set of the tidal volume and for the survey of the plateau pressure for the patients who require mechanical ventilation.
- The set of the PEEP (low or high levels) remains unclear : it seems that some patients need low levels of PEEP whereas anther need high levels; but there is no validated data that can discriminate them.
- We hypothesized that patients with low levels of EVLW ( measured with the Picco® system ) need low level of PEEP to ameliorate their oxygenation ( measured with the PaO2/FiO2 ratio ) whereas patients with high levels of EVLW) need high levels of PEEP.
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Mechanical ventilation, PEEP with low level, PEEP with high level, EVLW, Picco® system, PaO2/FiO2 ratio
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1: High level PEEP | Not described | |
| 2: Low level PEEP | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the Lung Water Extra-Vascular as predictive marker of the answer (Variation of needs in oxygen) to the ventilatory strategy: the low level, and high level of pressure positive expiratory, in the SDRA
Measured: During all the period of stay of the patient Intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJan 2009
- Primary completionFeb 2009 (estimated)
- Study completionFeb 2009 (estimated)
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.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Fady KARA, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714987
- Sponsor's protocol ID
- 3800
- Status last verified
- Sep 2009
- First submitted
- 7 Jul 2008
- Last updated
- 17 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of the Extra-Vascular Lung Water (EVLW) for the Alveolar Recruitment in the Acute Respiratory Distress Syndrome ( ARDS ).
- ClinicalTrials.gov ID
- NCT00714987
- Acronym / sponsor ID
- 3800
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Mechanical ventilation, PEEP with low level, PEEP with high level, EVLW, Picco® system, PaO2/FiO2 ratio
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Feb 2009 (estimated)
- First posted
- 14 Jul 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.
- ARDS is a severe pathology with high mortality and morbidity.Actual ventilatory management is clear for the set of the tidal volume and for the survey of the plateau pressure for the patients who require mechanical ventilation.
- The set of the PEEP (low or high levels) remains unclear : it seems that some patients need low levels of PEEP whereas anther need high levels; but there is no validated data that can discriminate them.
- We hypothesized that patients with low levels of EVLW ( measured with the Picco® system ) need low level of PEEP to ameliorate their oxygenation ( measured with the PaO2/FiO2 ratio ) whereas patients with high levels of EVLW) need high levels of PEEP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: High level PEEP | – | – |
| 2: Low level PEEP | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients mechanically ventilated, monitored with the Picco® system, hospitalized in a medical critical care unit of an university hospital
Key inclusion criteria (2 listed)
- age>18;
- ARDS criteria.
Key exclusion criteria (14 listed)
- severe pulmonary hypertension;
- chronic right ventricular failure;
- pulmonary embolism;
- tricuspidian valvulopathy;
- history of spontaneous pneumothorax;
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
Estimate the Lung Water Extra-Vascular as predictive marker of the answer (Variation of needs in oxygen) to the ventilatory strategy: the low level, and high level of pressure positive expiratory, in the SDRA
Time frame: During all the period of stay of the patient Intensive care unit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2009.
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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.
Fady KARA, MD principal investigator
University Hospital, Strasbourg, France
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by University Hospital, Strasbourg, France.
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 14 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: withdrawn, as of the sponsor's last update on 17 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Estimate the Lung Water Extra-Vascular as predictive marker of the answer (Variation of needs in oxygen) to the ventilatory strategy: the low level, and high level of pressure positive expiratory, in the SDRA (time frame: During all the period of stay of the patient Intensive care unit). 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 17 Sep 2009.