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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Respiratory Distress Syndrome (ARDS); Cerebral Injuries
• Intervention / Treatment: Other: alveolar recruitment maneuvers group 1; Other: alveolar recruitment maneuvers group 2

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 140033
    • UH Caen
  • Clermont-Ferrand, France, 63003
    • UH Clermont-Ferrand
  • Montpellier, France, 34295
    • UH Montpellier
  • Nantes, France, 44093
    • UH Nantes
  • Midi Pyrénées
    • Toulouse, Midi Pyrénées, France, 31059
      • UH Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alveolar recruitment maneuvers Group 1; alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh	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.
Experimental: Alveolar recruitment maneuvers Group 2; alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP	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.

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Ségolène MROZEK, MD, UH Toulouse

Publications and helpful links

General Publications

• Briel M, Meade M, Mercat A, Brower RG, Talmor D, Walter SD, Slutsky AS, Pullenayegum E, Zhou Q, Cook D, Brochard L, Richard JC, Lamontagne F, Bhatnagar N, Stewart TE, Guyatt G. Higher vs lower positive end-expiratory pressure in patients with acute lung injury and acute respiratory distress syndrome: systematic review and meta-analysis. JAMA. 2010 Mar 3;303(9):865-73. doi: 10.1001/jama.2010.218.
• Constantin JM, Jaber S, Futier E, Cayot-Constantin S, Verny-Pic M, Jung B, Bailly A, Guerin R, Bazin JE. Respiratory effects of different recruitment maneuvers in acute respiratory distress syndrome. Crit Care. 2008;12(2):R50. doi: 10.1186/cc6869. Epub 2008 Apr 16.
• Chesnut RM. Care of central nervous system injuries. Surg Clin North Am. 2007 Feb;87(1):119-56, vii. doi: 10.1016/j.suc.2006.09.018.
• Rangel-Castilla L, Gopinath S, Robertson CS. Management of intracranial hypertension. Neurol Clin. 2008 May;26(2):521-41, x. doi: 10.1016/j.ncl.2008.02.003.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): May 16, 2022
• Study Completion (Actual): May 16, 2022

Study Registration Dates

• First Submitted: September 19, 2015
• First Submitted That Met QC Criteria: October 8, 2015
• First Posted (Estimated): October 12, 2015

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Continuous Positive Airway Pressure (CPAP); Alveolar Recruitment Maneuvers (ARM); Extended Sigh (eSigh)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Respiratory Distress Syndrome
• Other Study ID Numbers: RC31/15/7604