Respiratory Distress Syndrome, AdultOPTIPEPNCT01256333
Optimization of Arterial Oxygen Transport by Positive End-expiratory Pressure Variation in Acute Respiratory Distress Syndrome
An observational study of Respiratory Distress Syndrome, Adult, run by Rennes University Hospital at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- How many people
- 12 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute respiratory distress syndrome
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Presence of a chest tube
- Pregnant or nursing mother
- Less than 18 years old
- Complete arrhythmia by atrial fibrillation
- Person under justice protection
Trial locations and contacts
2 sites in 1 country.
France2 sites
Perigueux Hospital
Périgueux, Aquitaine, 24019
Rennes University Hospital
Rennes, Britanny, 35033
About this study
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.
- Conditions
- Respiratory Distress Syndrome, Adult
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Determinate the Positive End-Expiratory Pressure (PEEP) level achieving the best arterial oxygen transport (TaO2)
Measured: 1 year
Secondary outcomes (4)
Evolution of pulmonary gas exchanges
Measured: 1 year
Evolution of respiratory mechanism parameters
Measured: 1 year
evolution of circulatory parameters and needs of catecholamine during the study
Measured: 1 year
Appearance of secondary effects due to mechanical ventilation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loic Chimot, Study director, CH de Périgueux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256333
- Sponsor's protocol ID
- 2010-A00942-37
- Other IDs
- LOC/10-08
- Acronym
- OPTIPEP
- Status last verified
- Jul 2013
- First submitted
- 6 Dec 2010
- Last updated
- 3 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Arterial Oxygen Transport by Positive End-expiratory Pressure Variation in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01256333
- Acronym / sponsor ID
- OPTIPEP / 2010-A00942-37
- Conditions
- Respiratory Distress Syndrome, Adult
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- First posted
- 8 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute respiratory distress syndrome
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determinate the Positive End-Expiratory Pressure (PEEP) level achieving the best arterial oxygen transport (TaO2)
Time frame: 1 year
4 secondary outcomes
Evolution of pulmonary gas exchanges
Time frame: 1 year
Evolution of respiratory mechanism parameters
Time frame: 1 year
evolution of circulatory parameters and needs of catecholamine during the study
Time frame: 1 year
Appearance of secondary effects due to mechanical ventilation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loic Chimot study director
CH de Périgueux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Adult, run by Rennes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determinate the Positive End-Expiratory Pressure (PEEP) level achieving the best arterial oxygen transport (TaO2) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.