Optimization of Arterial Oxygen Transport by Positive End... | NCT01256333

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

NCT01256333

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Jul 3, 2013Estimated

Enrollment

12Actual

Phase

Not provided

Conditions

Respiratory Distress Syndrome, Adult

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
LOC/10-08

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 6, 2010

First Submission Date that Met QC Criteria

Dec 7, 2010

First Posted Date

Dec 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2013

Last Update Posted Date

Jul 3, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determinate the Positive End-Expiratory Pressure (PEEP) level achieving the best arterial oxygen transport (TaO2)		1 year

Secondary Outcomes

Measure	Description	Time Frame
Evolution of pulmonary gas exchanges		1 year
Evolution of respiratory mechanism parameters		1 year
evolution of circulatory parameters and needs of catecholamine during the study

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with acute respiratory distress syndrome

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Perigueux Hospital		Périgueux	Aquitaine	24019	France
Rennes University Hospital

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders