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

Respiratory Distress Syndrome, Adult Clinical Trial

— OPTIPEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256333
• Other study ID #: 2010-A00942-37
• Secondary ID: LOC/10-08
• Status: Completed
• Phase: N/A
• First received: December 6, 2010
• Last updated: July 2, 2013
• Start date: January 2011

Study information

• Verified date: July 2013
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Locations

Country	Name	City	State
France	Perigueux Hospital	Perigueux	Aquitaine
France	Rennes University Hospital	Rennes	Britanny

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determinate the Positive End-Expiratory Pressure (PEEP) level achieving the best arterial oxygen transport (TaO2)		1 year	No
Secondary	Evolution of pulmonary gas exchanges		1 year	No
Secondary	Evolution of respiratory mechanism parameters		1 year	No
Secondary	evolution of circulatory parameters and needs of catecholamine during the study		1 year	No
Secondary	Appearance of secondary effects due to mechanical ventilation		1 year	No