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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Predictive Value of the Extra-Vascular Lung Water (EVLW) for the Alveolar Recruitment in the Acute Respiratory Distress Syndrome ( ARDS ).

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00714987
• Other study ID #: 3800
• Status: Withdrawn
• Phase: N/A
• First received: July 7, 2008
• Last updated: September 16, 2009
• Start date: January 2009
• Est. completion date: February 2009

Study information

• Verified date: September 2009
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical 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.

• 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 40
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No