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

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Respiratory Distress Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1: High level PEEP
2: Low level PEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Fady KARA, MD, University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): February 1, 2009
• Study Completion (Anticipated): February 1, 2009

Study Registration Dates

• First Submitted: July 7, 2008
• First Submitted That Met QC Criteria: July 11, 2008
• First Posted (Estimate): July 14, 2008

Study Record Updates

• Last Update Posted (Estimate): September 17, 2009
• Last Update Submitted That Met QC Criteria: September 16, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: ARDS; Mechanical ventilation; EVLW; PaO2/FiO2 ratio; PEEP with low level; PEEP with high level; Picco® system
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 3800