Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation (M'RHICO)

Toulouse University Hospital

Status: Enrolling

Conditions: Cerebral Injuries; Acute Respiratory Distress Syndrome (ARDS)

Treatments: Other: alveolar recruitment maneuvers group 2; Other: alveolar recruitment maneuvers group 1

Study type: Interventional

Funder types: Other

Identifiers

NCT02574169

RC31/15/7604

Details and patient eligibility

About

This study aims to compare 2 alveolar recruitment maneuvers (ARM) in patients with cerebral injuries and acute respiratory distress syndrome (ARDS) in term of efficacy and tolerance.

Full description

Two ARM are compared in this study:

The eSigh or extended sigh with increase of PEEP for 10 minutes to maintain plateau pressure at 40 cmH2O. During ARM, the peak pressure is limited to 50 cm H2O with decrease of tidal volume (Vt) if necessary. The continuous positive airway pressure, or Continuous Positive Airway Pressure (CPAP) with application of a positive pressure of 40 cm H2O for 40 seconds without tidal volume.

Patients are randomized to receive in cross-over 2 ARM: CPAP and Extended Sigh (eSigh). The following data: oxygen tissue partial pressure (PtiO2), respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each ARM.

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with brain injuries (subarachnoid hemorrhage, traumatic brain injury, ischemic and hemorrhagic stroke)
• Patients with moderate and severe ARDS criteria (as defined by classification of Berlin)
• Patients under mechanical ventilation

Exclusion criteria

• ICP (Intracranial pressure) > 25 mmHg
• Pregnant women
• Patients with history of chronic respiratory disease
• Patients with bronchopleural fistula
• Patients with hemodynamic instability despite appropriate measures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Alveolar recruitment maneuvers Group 1

Experimental group

Description:

alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh

Treatment:

Other: alveolar recruitment maneuvers group 1

Alveolar recruitment maneuvers Group 2

Experimental group

Description:

alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP

Treatment:

Other: alveolar recruitment maneuvers group 2