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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01256333
First received: December 6, 2010
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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
Respiratory Distress Syndrome, Adult

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Determinate the Positive End-Expiratory Pressure (PEEP) level achieving the best arterial oxygen transport (TaO2) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evolution of pulmonary gas exchanges [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evolution of respiratory mechanism parameters [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • evolution of circulatory parameters and needs of catecholamine during the study [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Appearance of secondary effects due to mechanical ventilation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: January 2011
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with acute respiratory distress syndrome

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256333

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

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01256333     History of Changes
Other Study ID Numbers: 2010-A00942-37, LOC/10-08
Study First Received: December 6, 2010
Last Updated: July 2, 2013
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

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

ClinicalTrials.gov processed this record on October 22, 2014