Optimization of Arterial Oxygen Transport by Positive End-expiratory Pressure Variation in Acute Respiratory Distress Syndrome (OPTIPEP)
This study is currently recruiting participants.
Verified November 2012 by Rennes University Hospital
Sponsor:
Rennes University Hospital
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01256333
First received: December 6, 2010
Last updated: November 14, 2012
Last verified: November 2012
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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 ]
| Estimated Enrollment: | 20 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256333
Contacts
| Contact: Loic chimot | 33-5-5345-2659 | loic.chimot@ch-perigueux.fr |
Locations
| France | |
| Perigueux Hospital | Recruiting |
| Perigueux, Aquitaine, France, 24019 | |
| Contact: chimot 33-5-5345-2659 loic.chimot@ch-perigueux.fr | |
| Principal Investigator: loic chimot | |
| Rennes University Hospital | Recruiting |
| Rennes, Britanny, France, 35033 | |
| Contact: arnaud gacouin 33-2-9928-4287 arnaud.gacoin@chu-rennes.fr | |
| Principal Investigator: arnaud gacouin | |
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: | November 14, 2012 |
| 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:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |
ClinicalTrials.gov processed this record on May 23, 2013