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

Sponsor

Centre Hospitalier Bretagne Atlantique (Other)

Overall Status

Completed

CT.gov ID

NCT02415738

Collaborator

(none)

Enrollment

Location

22.1

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

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.

Condition or Disease	Intervention/Treatment	Phase
ARDS Prone Positioning	Procedure: Prone positioning

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

Study Type:

Observational

Actual Enrollment :

10 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Outcome Measures

Primary Outcome Measures

Brain oxygenation [18 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.