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

NCT00714987 | Withdrawn

• 1 other identifier: 3800
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS; Mechanical ventilation; PEEP with low level; PEEP with high level; EVLW; Picco® system; PaO2/FiO2 ratio

Outcome Measures

Primary Outcomes (1)

• 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

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

Study Arms (2)

1: High level PEEP

2: Low level PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients mechanically ventilated, monitored with the Picco® system, hospitalized in a medical critical care unit of an university hospital

You may qualify if:

• age\>18;
• ARDS criteria.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Fady KARA, MD

  University Hospital, Strasbourg, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 14, 2008
• Study Start: January 1, 2009
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: September 17, 2009

Record last verified: 2009-09