Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation

Not Applicable

Recruiting

• Conditions: Acute Respiratory Distress Syndrome (ARDS); Cerebral Injuries
• Interventions: Other: alveolar recruitment maneuvers group 1; Other: alveolar recruitment maneuvers group 2

• Registration Number: NCT02574169
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Study First Submitted: 2015-09-19
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-12
• Study Start: 2016-09-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Alveolar recruitment maneuvers Group 1	alveolar recruitment maneuvers group 1	alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh
Alveolar recruitment maneuvers Group 2	alveolar recruitment maneuvers group 2	alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP

Primary Outcome Measures

Name	Time	Method
Comparison of oxygen tissue partial pressure (PtiO2) values	60 minutes	The comparison of PtiO2 values (mmHg, mean ± SD) 60 minutes after the 2 ARM: eSigh and CPAP

Secondary Outcome Measures

Name	Time	Method
Comparison of Intracranial hemodynamic parameters	60 minutes	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)
Comparison of arterial blood gases	60 minutes	Comparison between the two ARM of arterial blood gases (partial pressure of oxygen (PaO2),
Comparison of systemic hemodynamic parameters	60 minutes	Comparison between the two ARM of systemic hemodynamic parameters: mean arterial pressure, heart rate and cardiac output.
Comparison of blood oxygen level	60 minutes	Comparison between the two ARM of haematosis: Blood oxygen level (SpO2)
Comparison of partial pressure of carbon dioxide	60 minutes	Comparison between the two ARM of partial pressure of carbon dioxide (PaCO2),
Comparison of PtiO2	60 minutes	Comparison between the two ARM of PtiO2
Comparison of end-tidal CO2	60 minutes	Comparison between the two ARM of end-tidal CO2
Comparison of Respiratory parameters	60 minutes	Comparison between the two ARM of Respiratory parameters: plateau pressure and static lung compliance.

Trial Locations

Locations (5)

UH Toulouse; 🇫🇷 Toulouse, Midi Pyrénées, France

UH Caen; 🇫🇷 Caen, France

UH Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

UH Montpellier; 🇫🇷 Montpellier, France

UH Nantes; 🇫🇷 Nantes, France