Optimization of Arterial Oxygen Transport by Positive End-expiratory Pressure Variation in Acute Respiratory Distress Syndrome

NCT01256333 | Completed

• 2 other identifiers: 2010-A00942-37LOC/10-08
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

Despite improving in the treatment of acute respiratory distress syndrome (ARDS), this affection keep an elevate rate of death. The strategy of mechanical ventilation is more and more under definite protocol, following large strength randomized studies. Although, it doesn't exist today element allowing to adjust the level of Positive End-Expiratory Pressure (PEEP) with improvement in patient's survival. The investigators proposed in this study to determinate the level of PEEP adjust to obtain the better arterial oxygen transport (TaO2). The investigators going to conduct a physiologic, observational, none controlled study. All patients hospitalized in intensive care unit of Pontchaillou hospital with ARDS criteria and without specific exclusion criteria will be included. Primary objective is to looking for the optimum level of PEEP for TaO2.

Conditions

Respiratory Distress Syndrome, Adult

Outcome Measures

Primary Outcomes (1)

• Determinate the Positive End-Expiratory Pressure (PEEP) level achieving the best arterial oxygen transport (TaO2)

  1 year

Secondary Outcomes (4)

• Evolution of pulmonary gas exchanges

  1 year

• Evolution of respiratory mechanism parameters

  1 year

• evolution of circulatory parameters and needs of catecholamine during the study

  1 year

• Appearance of secondary effects due to mechanical ventilation

  1 year

Eligibility Criteria

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

Study Population

Patients with acute respiratory distress syndrome

You may qualify if:

• patient presenting a Acute Respiratory Distress Syndrone (ARDS) definite by : acute respiratory failure, bilateral alveolo-interstitial infiltrate on chest radiography, absence of increased left ventricular filling pressure, partial pressure of oxygen in arterial blood (PaO2)/Fraction of inspired oxygen(FiO2) \<200 and Positive End-Expiratory Pressure (PEEP) \> or equal to 5 cmH2O
• Need to invasive mechanical ventilation
• Precedent criteria persisting at least 6 hours
• Haemoglobin \> 8g/dl
• Ramsay score at 6

You may not qualify if:

• Participation to en other study on the Acute Respiratory Distress Syndrone (ARDS) with the same end-point
• Presence of external circulatory assist
• Left Ventricular Ejection fraction (LVEF)or Left ventricular shortening fraction (LVSF)\< 40% after correction of hypovolemia and/or vasoplegia
• Infusion of inotrope
• Presence of Acute Pulmonary Heart
• Following procedure : ExtraCorporeal Membrane Oxygenation(ECMO), prone position, inhalation of Nitrogen dioxyde
• Presence of a chest tube
• Pregnant or nursing mother
• Less than 18 years old
• Complete arrhythmia by atrial fibrillation
• Person under justice protection

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (2)

Perigueux Hospital

Périgueux, Aquitaine, 24019, France

Location

Rennes University Hospital

Rennes, Britanny, 35033, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Loic Chimot

  CH de Périgueux

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 8, 2010
• Study Start: January 1, 2011
• Last Updated: July 3, 2013

Record last verified: 2013-07

Locations

FR (2)