WithdrawnNot Applicable

The EVLW for Set the Positive End Expiratory Pressure (PEEP) in the Acute Respiratory Distress Syndrome (ARDS)

40 participantsStarted 2009-01

Plain-language 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. * 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age\>18; * ARDS criteria. Exclusion Criteria: * severe pulmonary hypertension; * chronic right ventricular failure; * pulmonary embolism; * tricuspidian valvulopathy; * history of spontaneous pneumothorax; * severe emphysema; * bronchomalacia; * recent pulmonary surgery; * BMI\>40; * Interstitial pulmonary fibrosis; * End of life; * Chronic neuromyopathie; * Recent neurosurgery or intracranian hypertension; * Pregnancy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: During all the period of stay of the patient Intensive care unit

Trial details

NCT IDNCT00714987

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2009-02

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome trials