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

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.

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Key information

Conditions

Respiratory Distress Syndrome, Adult Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Perigueux Hospital, Périgueux, Aquitaine, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 1 year

Secondary outcomes

Evolution of pulmonary gas exchanges

Time frame: 1 year
Evolution of respiratory mechanism parameters

Time frame: 1 year
evolution of circulatory parameters and needs of catecholamine during the study

Time frame: 1 year
Appearance of secondary effects due to mechanical ventilation

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: OPTIPEP

Important dates

Study start: 2011
First posted: Dec 8, 2010
Registry last updated: Jul 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed