Clinical trial NCT01256333: Optimization of Arterial Oxygen Transport by Positive End-expiratory Pressure Variation in Acute Respiratory Distress Syndrome
Official title: Optimization of Arterial Oxygen Transport by Positive End-expiratory Pressure Variation in Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Adult
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2010-12-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute respiratory distress syndrome

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Determinate the Positive End-Expiratory Pressure (PEEP) level achieving the best arterial oxygen transport (TaO2)
timeFrame: 1 year
Secondary outcomes:
measure: Evolution of pulmonary gas exchanges
timeFrame: 1 year
measure: Evolution of respiratory mechanism parameters
timeFrame: 1 year
measure: evolution of circulatory parameters and needs of catecholamine during the study
timeFrame: 1 year
measure: Appearance of secondary effects due to mechanical ventilation
timeFrame: 1 year
Other outcomes:
Locations:
city: Perigueux
country: France
facility: Perigueux Hospital
state: Aquitaine
city: Rennes
country: France
facility: Rennes University Hospital
state: Britanny
Study officials:
affiliation: CH de Périgueux
name: Loic Chimot
role: STUDY_DIRECTOR
References: