Changes in Cerebral Oxygenation During the Prone Position in Patients With Acute Respiratory Distress Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02415738
• Date of registration: 09/04/2015
• Prospective Registration: No
• Primary sponsor: Centre Hospitalier Bretagne Atlantique
• Public title: Changes in Cerebral Oxygenation During the Prone Position in Patients With Acute Respiratory Distress Syndrome OXYDV
• Scientific title: Changes in Cerebral Oxygenation During the Prone Position in Patients With Acute Respiratory Distress Syndrome
• Date of first enrolment: April 2015
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02415738
• Study type: Observational
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Prone Positioning

ARDS

Intervention(s)

Procedure: Prone positioning

Primary Outcome(s)

Brain oxygenation [Time Frame: 18 hours]

Secondary ID(s)

2015-005-YF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors