Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation

Conditions
-----------------
Cerebral Injuries, Acute Respiratory Distress Syndrome (ARDS)

Intervention / Treatment
-----------------
* Other: alveolar recruitment maneuvers group 1
* Other: alveolar recruitment maneuvers group 2


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alveolar recruitment maneuvers Group 1<br>alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh | Other: alveolar recruitment maneuvers group 1<br>* Patients are randomized to receive in cross-over 2 ARM: CPAP at first and then eSigh. The continuous positive airway pressure, or CPAP with application of a positive pressure of 40 cmH2O for 40 seconds without tidal volume. 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 cmH2O with decrease of tidal volume (Vt) if necessary. The following data: PtiO2, respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each ARM.<br>|
| Experimental: Alveolar recruitment maneuvers Group 2<br>alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP | Other: alveolar recruitment maneuvers group 2<br>* Patients are randomized to receive in cross-over 2 ARM: eSigh at first and then CPAP. 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 cmH2O with decrease of tidal volume (Vt) if necessary. The continuous positive airway pressure, or CPAP with application of a positive pressure of 40 cmH2O for 40 seconds without tidal volume. The following data: PtiO2, respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each ARM.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of oxygen tissue partial pressure (PtiO2) values | The comparison of PtiO2 values (mmHg, mean ± SD) 60 minutes after the 2 ARM: eSigh and CPAP | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of systemic hemodynamic parameters | Comparison between the two ARM of systemic hemodynamic parameters: mean arterial pressure, heart rate and cardiac output. | 60 minutes | 
| Comparison of Intracranial hemodynamic parameters | Comparison between the two ARM of Intracranial hemodynamic parameters: ICP (Intracranial pressure) , cerebral perfusion pressure and Transcranial Doppler (pulsatility index, mean, systolic and diastolic velocities) | 60 minutes | 
| Comparison of blood oxygen level | Comparison between the two ARM of haematosis: Blood oxygen level (SpO2) | 60 minutes | 
| Comparison of partial pressure of carbon dioxide | Comparison between the two ARM of partial pressure of carbon dioxide (PaCO2), | 60 minutes | 
| Comparison of arterial blood gases | Comparison between the two ARM of arterial blood gases (partial pressure of oxygen (PaO2), | 60 minutes | 
| Comparison of end-tidal CO2 | Comparison between the two ARM of end-tidal CO2 | 60 minutes | 
| Comparison of Respiratory parameters | Comparison between the two ARM of Respiratory parameters: plateau pressure and static lung compliance. | 60 minutes | 
| Comparison of PtiO2 | Comparison between the two ARM of PtiO2 | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alveolar Recruitment Maneuvers (ARM), Continuous Positive Airway Pressure (CPAP), Extended Sigh (eSigh)