NCT02574169

Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Injuries
• Acute Respiratory Distress Syndrome (ARDS)

Interventions

Type	Name	Description
OTHER	alveolar recruitment maneuvers group 1	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.
OTHER	alveolar recruitment maneuvers group 2	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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2015-10-12
• Last updated: 2024-09-25

Locations

5 sites across 1 country: France