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

NCT02415738 | Completed

• 1 other identifier: 2015-005-YF
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS; Prone Positioning

Keywords

Near infrared spectroscopy; Cerebral oxygenation; Acute respiratory distress syndrom; Prone positioning

Outcome Measures

Primary Outcomes (1)

• Brain oxygenation

  18 hours

Interventions

Prone positioning PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ARDS

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Bretagne Atlantique: lead

Study Sites (1)

CHBA

Vannes, 56 000, France

Location

MeSH Terms

Interventions

Prone Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 14, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

FR (1)