ARDSOXYDVNCT02415738
Changes in Cerebral Oxygenation During the Prone Position in Patients With Acute Respiratory Distress Syndrome
An observational study of ARDS and Prone Positioning, run by Centre Hospitalier Bretagne Atlantique at 1 site in France.
Trial summary
Hypoxemia may be refractory to protective ventilation during the acute respiratory distress syndrome (ARDS), justifying the use of other therapies that improved oxygenation and decreased mortality, including prone position (PP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Prone Positioning
- What is being tested?
- Prone positioning
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Feb 2017
- 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: ARDS
Who may be able to join
- Patient with moderate and severe ARDS from 12h, defined by:
- Acute onset of respiratory failure
- Parenchymal opacities Bilateral not fully explained by pleural effusion, nodules, masses or atelectasis
- Unexplained cardiac or vascular insufficiency filling respiratory distress
- PaO2 / FiO2 ≤ 200 with FiO2> 60% and PEEP ≥ 5cmH2O
- Need for invasive mechanical ventilation
- Hemoglobin> 8 g / dL
- Ramsay score 6 sedated with midazolam and Sufentanyl and neuromuscular blockade by Atracurium.
Who cannot join
- Participation in another study requiring specific management of ARDS;
- Against-indication for prone position:
- Burns or wounds in the face, chest and abdominal wall
- Recent thoraco-abdominal surgical incision
- Spinal instability, pelvic fracture
- State of uncontrolled shock
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- intracranial hypertension
- Alteration of the NIRS signal:
- Brain damage: extra-dural hematoma, subdural hematoma, pneumocephalus, ischemic stroke, subarachnoid hemorrhage, intracerebral expansive process
- Skin lesions at the electrodes
- Jaundice bilirubin
- ECMO
- Pregnant or breastfeeding women
- Age less than 18 years
- Opposition patient, a family member, person of trust or the legal representative for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Hypoxemia may be refractory to protective ventilation during the acute respiratory distress syndrome (ARDS), justifying the use of other therapies that improved oxygenation and decreased mortality, including prone position (PP).
During ARDS, the majority of patients are responders to PP with increased PaO2 due to homogenization of the ventilation-perfusion ratio. Despite changes in intra-thoracic and intra-abdominal pressure, hemodynamic parameters are not changed.
Read more
Besides the fact that the PP improves systemic oxygenation is it the same on cerebral oxygenation? No study has investigated the cerebral oxygenation during PP in patients with ARDS. The cerebral oxygenation may be altered due to the position of the patient and high levels of positive end-expiratory pressure. This decrease oxygenation may be responsible for cognitive impairment when patients awake.
NIRS (Near Infrared Spectroscopy) is a noninvasive tool, capable of delivering information on cerebral oxidative metabolism and its hemodynamic status. It can be used routinely for the management of resuscitation in Intensive Care Unit (ICU) patients. This study is to investigate cerebral oxygenation during prone position in the investigators' patients of ICU.
Read the detailed description
Primary objectiv Is there a correlation between rSO2 and SpO2 during prone position in patients with ARDS?
Inclusion criteria
Patient with moderate and severe ARDS from 12h, defined by:
- Acute onset of respiratory failure
- Parenchymal opacities Bilateral not fully explained by pleural effusion, nodules, masses or atelectasis
- Unexplained cardiac or vascular insufficiency filling respiratory distress
- PaO2 / FiO2 ≤ 200 with FiO2> 60% and PEEP ≥ 5cmH2O
- Need for invasive mechanical ventilation
- Hemoglobin> 8 g / dL
- Ramsay score 6 sedated with midazolam and Sufentanyl and neuromuscular blockade by Atracurium.
Exclusion criteria
- Participation in another study requiring specific management of ARDS;
- Against-indication for prone position:
- Burns or wounds in the face, chest and abdominal wall
- Recent thoraco-abdominal surgical incision
- Spinal instability, pelvic fracture
- State of uncontrolled shock
- intracranial hypertension
- Alteration of the NIRS signal:
- Brain damage: extra-dural hematoma, subdural hematoma, pneumocephalus, ischemic stroke, subarachnoid hemorrhage, intracerebral expansive process
- Skin lesions at the electrodes
- Jaundice bilirubin
- ECMO
- Pregnant or breastfeeding women
- Age less than 18 years
- Opposition patient, a family member, person of trust or the legal representative for participation in the study.
- Conditions
- ARDS, Prone Positioning
- Being tested
- Prone positioning
- Keywords
- Near infrared spectroscopy, Cerebral oxygenation, Acute respiratory distress syndrom, Prone positioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positioningProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain oxygenation
Measured: 18 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Bretagne Atlantique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415738
- Sponsor's protocol ID
- 2015-005-YF
- Acronym
- OXYDV
- Status last verified
- Mar 2017
- First submitted
- 9 Apr 2015
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cerebral Oxygenation During the Prone Position in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02415738
- Acronym / sponsor ID
- OXYDV / 2015-005-YF
- Conditions
- ARDS, Prone Positioning
- Keywords
- Near infrared spectroscopy, Cerebral oxygenation, Acute respiratory distress syndrom, Prone positioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Bretagne AtlantiqueUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 14 Apr 2015 (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.
Hypoxemia may be refractory to protective ventilation during the acute respiratory distress syndrome (ARDS), justifying the use of other therapies that improved oxygenation and decreased mortality, including prone position (PP).
During ARDS, the majority of patients are responders to PP with increased PaO2 due to homogenization of the ventilation-perfusion ratio. Despite changes in intra-thoracic and intra-abdominal pressure, hemodynamic parameters are not changed.
Besides the fact that the PP improves systemic oxygenation is it the same on cerebral oxygenation? No study has investigated the cerebral oxygenation during PP in patients with ARDS. The cerebral oxygenation may be altered due to the position of the patient and high levels of positive end-expiratory pressure. This decrease oxygenation may be responsible for cognitive impairment when patients awake.
NIRS (Near Infrared Spectroscopy) is a noninvasive tool, capable of delivering information on cerebral oxidative metabolism and its hemodynamic status. It can be used routinely for the management of resuscitation in Intensive Care Unit (ICU) patients. This study is to investigate cerebral oxygenation during prone position in the investigators' patients of ICU.
Detailed description
Primary objectiv Is there a correlation between rSO2 and SpO2 during prone position in patients with ARDS?
Inclusion criteria
Patient with moderate and severe ARDS from 12h, defined by:
- Acute onset of respiratory failure
- Parenchymal opacities Bilateral not fully explained by pleural effusion, nodules, masses or atelectasis
- Unexplained cardiac or vascular insufficiency filling respiratory distress
- PaO2 / FiO2 ≤ 200 with FiO2> 60% and PEEP ≥ 5cmH2O
- Need for invasive mechanical ventilation
- Hemoglobin> 8 g / dL
- Ramsay score 6 sedated with midazolam and Sufentanyl and neuromuscular blockade by Atracurium.
Exclusion criteria
- Participation in another study requiring specific management of ARDS;
- Against-indication for prone position:
- Burns or wounds in the face, chest and abdominal wall
- Recent thoraco-abdominal surgical incision
- Spinal instability, pelvic fracture
- State of uncontrolled shock
- intracranial hypertension
- Alteration of the NIRS signal:
- Brain damage: extra-dural hematoma, subdural hematoma, pneumocephalus, ischemic stroke, subarachnoid hemorrhage, intracerebral expansive process
- Skin lesions at the electrodes
- Jaundice bilirubin
- ECMO
- Pregnant or breastfeeding women
- Age less than 18 years
- Opposition patient, a family member, person of trust or the legal representative for participation in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ARDS
Key inclusion criteria (8 listed)
- Acute onset of respiratory failure
- Parenchymal opacities Bilateral not fully explained by pleural effusion, nodules, masses or atelectasis
- Unexplained cardiac or vascular insufficiency filling respiratory distress
- PaO2 / FiO2 ≤ 200 with FiO2> 60% and PEEP ≥ 5cmH2O
- Need for invasive mechanical ventilation
Key exclusion criteria (15 listed)
- Participation in another study requiring specific management of ARDS;
- Against-indication for prone position:
- Alteration of the NIRS signal:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone positioning | Procedure or surgery | – |
Primary outcome
Brain oxygenation
Time frame: 18 hours
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 13 Mar 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS and Prone Positioning, run by Centre Hospitalier Bretagne Atlantique at 1 site 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 8 inclusion and 15 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 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Brain oxygenation (time frame: 18 hours). 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 13 Mar 2017.