Changes in Cerebral Oxygenation During the Prone Position in Patients With Acute Respiratory Distress Syndrome
Keywords
Abstract
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.
Dates
| Last Verified: | 02/28/2017 |
| First Submitted: | 04/08/2015 |
| Estimated Enrollment Submitted: | 04/12/2015 |
| First Posted: | 04/13/2015 |
| Last Update Submitted: | 03/08/2017 |
| Last Update Posted: | 03/12/2017 |
| Actual Study Start Date: | 03/31/2015 |
| Estimated Primary Completion Date: | 01/31/2017 |
| Estimated Study Completion Date: | 01/31/2017 |
Condition or disease
Intervention/treatment
Procedure: Prone positioning
Phase
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. Brain oxygenation [18 hours]
