Cerebral InjuriesM'RHICONCT02574169
Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation
A study testing alveolar recruitment maneuvers group 1 and alveolar recruitment maneuvers group 2 in people with Cerebral Injuries and Acute Respiratory Distress Syndrome (ARDS), run by University Hospital, Toulouse at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Injuries, Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- alveolar recruitment maneuvers group 1 and alveolar recruitment maneuvers group 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Sep 2016to 16 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
UH Caen
Caen, 140033
UH Clermont-Ferrand
Clermont-Ferrand, 63003
UH Montpellier
Montpellier, 34295
UH Nantes
Nantes, 44093
UH Toulouse
Toulouse, Midi Pyrénées, 31059
About this study
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.
Read the 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.
- Being tested
- alveolar recruitment maneuvers group 1, alveolar recruitment maneuvers group 2
- Keywords
- Alveolar Recruitment Maneuvers (ARM), Continuous Positive Airway Pressure (CPAP), Extended Sigh (eSigh)
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar recruitment maneuvers group 1Other
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.
alveolar recruitment maneuvers group 2Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Alveolar recruitment maneuvers Group 1 | Experimental | alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh Receives: Other: alveolar recruitment maneuvers group 1 |
| Alveolar recruitment maneuvers Group 2 | Experimental | alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP Receives: Other: alveolar recruitment maneuvers group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 minutes
Secondary outcomes (8)
Comparison of systemic hemodynamic parameters
Comparison between the two ARM of systemic hemodynamic parameters: mean arterial pressure, heart rate and cardiac output.
Measured: 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)
Measured: 60 minutes
Comparison of blood oxygen level
Comparison between the two ARM of haematosis: Blood oxygen level (SpO2)
Measured: 60 minutes
Comparison of partial pressure of carbon dioxide
Comparison between the two ARM of partial pressure of carbon dioxide (PaCO2),
Measured: 60 minutes
Comparison of arterial blood gases
Comparison between the two ARM of arterial blood gases (partial pressure of oxygen (PaO2),
Measured: 60 minutes
Comparison of end-tidal CO2
Comparison between the two ARM of end-tidal CO2
Measured: 60 minutes
Comparison of Respiratory parameters
Comparison between the two ARM of Respiratory parameters: plateau pressure and static lung compliance.
Measured: 60 minutes
Comparison of PtiO2
Comparison between the two ARM of PtiO2
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start1 Sep 2016
- Primary completion16 May 2022
- Study completion16 May 2022
Why it stopped: Difficulty with inclusion, demotivation of centers in general
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ségolène MROZEK, MD, Principal investigator, UH TOULOUSE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574169
- Sponsor's protocol ID
- RC31/15/7604
- Acronym
- M'RHICO
- Status last verified
- May 2026
- First submitted
- 19 Sep 2015
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18416847Rangel-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.
PubMed 18514825Chesnut 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.
PubMed 17127126Briel 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.
PubMed 20197533
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation
- ClinicalTrials.gov ID
- NCT02574169
- Acronym / sponsor ID
- M'RHICO / RC31/15/7604
- Keywords
- Alveolar Recruitment Maneuvers (ARM), Continuous Positive Airway Pressure (CPAP), Extended Sigh (eSigh)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with inclusion, demotivation of centers in general
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alveolar recruitment maneuvers Group 1 | Experimental | Other: alveolar recruitment maneuvers group 1alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh |
| Alveolar recruitment maneuvers Group 2 | Experimental | Other: alveolar recruitment maneuvers group 2alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alveolar recruitment maneuvers group 1Patients 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 1 |
| alveolar recruitment maneuvers group 2Patients 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. | Other | Alveolar recruitment maneuvers Group 2 |
Primary outcome
Comparison of oxygen tissue partial pressure (PtiO2) values
Time frame: 60 minutes
The comparison of PtiO2 values (mmHg, mean ± SD) 60 minutes after the 2 ARM: eSigh and CPAP
8 secondary outcomes
Comparison of systemic hemodynamic parameters
Time frame: 60 minutes
Comparison of Intracranial hemodynamic parameters
Time frame: 60 minutes
Comparison of blood oxygen level
Time frame: 60 minutes
Comparison of partial pressure of carbon dioxide
Time frame: 60 minutes
Comparison of arterial blood gases
Time frame: 60 minutes
Comparison of end-tidal CO2
Time frame: 60 minutes
Comparison of Respiratory parameters
Time frame: 60 minutes
Comparison of PtiO2
Time frame: 60 minutes
Results and safety
The study was stopped early (reason given: Difficulty with inclusion, demotivation of centers in general). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 18416847Constantin 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.
- Background: PubMed 18514825Rangel-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.
- Background: PubMed 17127126Chesnut 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.
- Background: PubMed 20197533Briel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ségolène MROZEK, MD principal investigator
UH TOULOUSE
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alveolar recruitment maneuvers group 1 and alveolar recruitment maneuvers group 2 in people with Cerebral Injuries and Acute Respiratory Distress Syndrome (ARDS), run by University Hospital, Toulouse at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty with inclusion, demotivation of centers in general). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of oxygen tissue partial pressure (PtiO2) values (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574169, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.