Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation (M'RHICO)
Primary Purpose
Cerebral Injuries, Acute Respiratory Distress Syndrome (ARDS)
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
alveolar recruitment maneuvers group 1
alveolar recruitment maneuvers group 2
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Injuries focused on measuring Alveolar Recruitment Maneuvers (ARM), Continuous Positive Airway Pressure (CPAP), Extended Sigh (eSigh)
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
Sites / Locations
- UH ToulouseRecruiting
- UH CaenRecruiting
- UH Clermont-FerrandRecruiting
- UH MontpellierRecruiting
- UH NantesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Alveolar recruitment maneuvers Group 1
Alveolar recruitment maneuvers Group 2
Arm Description
alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh
alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Comparison of systemic hemodynamic parameters
Comparison between the two ARM of systemic hemodynamic parameters: mean arterial pressure, heart rate and cardiac output.
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)
Comparison of blood oxygen level
Comparison between the two ARM of haematosis: Blood oxygen level (SpO2)
Comparison of partial pressure of carbon dioxide
Comparison between the two ARM of partial pressure of carbon dioxide (PaCO2),
Comparison of arterial blood gases
Comparison between the two ARM of arterial blood gases (partial pressure of oxygen (PaO2),
Comparison of end-tidal CO2
Comparison between the two ARM of end-tidal CO2
Comparison of Respiratory parameters
Comparison between the two ARM of Respiratory parameters: plateau pressure and static lung compliance.
Comparison of PtiO2
Comparison between the two ARM of PtiO2
Full Information
NCT ID
NCT02574169
First Posted
September 19, 2015
Last Updated
July 21, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02574169
Brief Title
Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation
Acronym
M'RHICO
Official Title
Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Injuries, Acute Respiratory Distress Syndrome (ARDS)
Keywords
Alveolar Recruitment Maneuvers (ARM), Continuous Positive Airway Pressure (CPAP), Extended Sigh (eSigh)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alveolar recruitment maneuvers Group 1
Arm Type
Experimental
Arm Description
alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh
Arm Title
Alveolar recruitment maneuvers Group 2
Arm Type
Experimental
Arm Description
alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP
Intervention Type
Other
Intervention Name(s)
alveolar recruitment maneuvers group 1
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
alveolar recruitment maneuvers group 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of oxygen tissue partial pressure (PtiO2) values
Description
The comparison of PtiO2 values (mmHg, mean ± SD) 60 minutes after the 2 ARM: eSigh and CPAP
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Comparison of systemic hemodynamic parameters
Description
Comparison between the two ARM of systemic hemodynamic parameters: mean arterial pressure, heart rate and cardiac output.
Time Frame
60 minutes
Title
Comparison of Intracranial hemodynamic parameters
Description
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)
Time Frame
60 minutes
Title
Comparison of blood oxygen level
Description
Comparison between the two ARM of haematosis: Blood oxygen level (SpO2)
Time Frame
60 minutes
Title
Comparison of partial pressure of carbon dioxide
Description
Comparison between the two ARM of partial pressure of carbon dioxide (PaCO2),
Time Frame
60 minutes
Title
Comparison of arterial blood gases
Description
Comparison between the two ARM of arterial blood gases (partial pressure of oxygen (PaO2),
Time Frame
60 minutes
Title
Comparison of end-tidal CO2
Description
Comparison between the two ARM of end-tidal CO2
Time Frame
60 minutes
Title
Comparison of Respiratory parameters
Description
Comparison between the two ARM of Respiratory parameters: plateau pressure and static lung compliance.
Time Frame
60 minutes
Title
Comparison of PtiO2
Description
Comparison between the two ARM of PtiO2
Time Frame
60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ségolène MROZEK, MD
Phone
05 61 77 21 67
Ext
+33
Email
mrozek.s@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey Tomasik
Phone
05 61 77 85 97
Email
tomasik.a@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ségolène MROZEK, MD
Organizational Affiliation
UH TOULOUSE
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Toulouse
City
Toulouse
State/Province
Midi Pyrénées
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ségolène MROZEK, MD
Phone
05 61 77 21 67
Ext
+33
Email
mrozek.s@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Thomas GEERAERTS, MD
Phone
05 61 77 21 00
Ext
+33
Email
geeraerts.t@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Ségolène MROZEK, MD
First Name & Middle Initial & Last Name & Degree
Thomas GEERAERTS, MD
First Name & Middle Initial & Last Name & Degree
Béatrice RIU, MD
Facility Name
UH Caen
City
Caen
ZIP/Postal Code
140033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc-Olivier FISCHER, MD
Phone
02 31 06 33 03
Ext
+33
Email
marcolivierfischer@yahoo.fr
Facility Name
UH Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rusell CHABANNE, MD
Phone
04 73 75 16 48
Ext
+33
Email
rchabanne@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Jean-Michel CONSTANTIN, MD
Phone
04 73 75 05 01
Ext
+33
Email
jmconstantin@chu-clermontferrand.fr
Facility Name
UH Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-François PERRIGAUT
Phone
04 67 33 76 87
Ext
+33
Email
pf-perrigault@chu-montpellier.fr
Facility Name
UH Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine ROQUILLY, MD
Phone
02 40 08 30 08
Ext
+33
Email
antoine.roquilly@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
18416847
Citation
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.
Results Reference
background
PubMed Identifier
18514825
Citation
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. Erratum In: Neurol Clin. 2008 Aug;26(3):xvii. Rangel-Castillo, Leonardo [corrected to Rangel-Castilla, Leonardo].
Results Reference
background
PubMed Identifier
17127126
Citation
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.
Results Reference
background
PubMed Identifier
20197533
Citation
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.
Results Reference
background
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Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation
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