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CompletedNCT01256333OPTIPEPUpdated Jul 3, 2013

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

An observational study in Respiratory Distress Syndrome, Adult, sponsored by Rennes University Hospital. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-07-03.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Respiratory Distress Syndrome, Adult
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In context

Respiratory Distress Syndrome

1,619 studies on the registry are indexed under Respiratory Distress Syndrome; 319 are open to participants now.

This study's enrollment of 12 is below the median of 100 across 548 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute respiratory distress syndrome

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
12 participants (actual)
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What researchers measure

Primary outcomes

  1. Determinate the Positive End-Expiratory Pressure (PEEP) level achieving the best arterial oxygen transport (TaO2)

    Time frame: 1 year

Secondary outcomes

  1. Evolution of pulmonary gas exchanges

    Time frame: 1 year

  2. Evolution of respiratory mechanism parameters

    Time frame: 1 year

  3. evolution of circulatory parameters and needs of catecholamine during the study

    Time frame: 1 year

  4. Appearance of secondary effects due to mechanical ventilation

    Time frame: 1 year

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Study locations

2 sites
  • Perigueux Hospital
    Périgueux, Aquitaine 24019, France
  • Rennes University Hospital
    Rennes, Britanny 35033, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01256333
Responsible party
Sponsor
First posted
Dec 8, 2010
Start date
Jan 2011
Last update
Jul 3, 2013

Study contacts

Loic Chimot
study director · CH de Périgueux
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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