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

NCT ID: NCT01256333

Last Updated: 2013-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Distress Syndrome, Adult

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Loic Chimot

Role: STUDY_DIRECTOR

CH de Périgueux

Locations

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Perigueux Hospital

Périgueux, Aquitaine, France

Site Status

Rennes University Hospital

Rennes, Britanny, France

Site Status

Countries

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France

Other Identifiers

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LOC/10-08

Identifier Type: -

Identifier Source: secondary_id

2010-A00942-37

Identifier Type: -

Identifier Source: org_study_id

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