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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01256333
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : July 3, 2013
Information provided by (Responsible Party):
Rennes University Hospital

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.

Condition or disease
Respiratory Distress Syndrome, Adult

Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optimization of Arterial Oxygen Transport by Positive End-expiratory Pressure Variation in Acute Respiratory Distress Syndrome
Study Start Date : January 2011

Primary Outcome Measures :
  1. Determinate the Positive End-Expiratory Pressure (PEEP) level achieving the best arterial oxygen transport (TaO2) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Evolution of pulmonary gas exchanges [ Time Frame: 1 year ]
  2. Evolution of respiratory mechanism parameters [ Time Frame: 1 year ]
  3. evolution of circulatory parameters and needs of catecholamine during the study [ Time Frame: 1 year ]
  4. Appearance of secondary effects due to mechanical ventilation [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute respiratory distress syndrome

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01256333

Perigueux Hospital
Perigueux, Aquitaine, France, 24019
Rennes University Hospital
Rennes, Britanny, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Study Director: Loic Chimot CH de Périgueux

Responsible Party: Rennes University Hospital Identifier: NCT01256333     History of Changes
Other Study ID Numbers: 2010-A00942-37
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury