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TerminatedNCT02574169M'RHICOUpdated Jun 1, 2026

Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation

An interventional study of alveolar recruitment maneuvers group 1 and alveolar recruitment maneuvers group 2 in Cerebral Injuries and Acute Respiratory Distress Syndrome (ARDS), sponsored by University Hospital, Toulouse. Terminated at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment

Why this study was terminated
Difficulty with inclusion, demotivation of centers in general
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cerebral Injuries
  • Acute Respiratory Distress Syndrome (ARDS)

Keywords

  • Alveolar Recruitment Maneuvers (ARM)
  • Continuous Positive Airway Pressure (CPAP)
  • Extended Sigh (eSigh)
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 18 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Enrollment
18 participants (actual)

Study arms

  • Experimental
    Alveolar recruitment maneuvers Group 1

    alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh

    Other: alveolar recruitment maneuvers group 1

  • Experimental
    Alveolar recruitment maneuvers Group 2

    alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP

    Other: alveolar recruitment maneuvers group 2

Interventions

  • Otheralveolar 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.

  • Otheralveolar 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 60 minutes

Secondary outcomes

  1. Comparison of systemic hemodynamic parameters

    Comparison between the two ARM of systemic hemodynamic parameters: mean arterial pressure, heart rate and cardiac output.

    Time frame: 60 minutes

  2. 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)

    Time frame: 60 minutes

  3. Comparison of blood oxygen level

    Comparison between the two ARM of haematosis: Blood oxygen level (SpO2)

    Time frame: 60 minutes

  4. Comparison of partial pressure of carbon dioxide

    Comparison between the two ARM of partial pressure of carbon dioxide (PaCO2),

    Time frame: 60 minutes

  5. Comparison of arterial blood gases

    Comparison between the two ARM of arterial blood gases (partial pressure of oxygen (PaO2),

    Time frame: 60 minutes

  6. Comparison of end-tidal CO2

    Comparison between the two ARM of end-tidal CO2

    Time frame: 60 minutes

  7. Comparison of Respiratory parameters

    Comparison between the two ARM of Respiratory parameters: plateau pressure and static lung compliance.

    Time frame: 60 minutes

  8. Comparison of PtiO2

    Comparison between the two ARM of PtiO2

    Time frame: 60 minutes

07

Study locations

5 sites
  • UH Toulouse
    Toulouse, Midi Pyrénées 31059, France
  • UH Caen
    Caen, 140033, France
  • UH Clermont-Ferrand
    Clermont-Ferrand, 63003, France
  • UH Montpellier
    Montpellier, 34295, France
  • UH Nantes
    Nantes, 44093, France
08

References and documents

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 18416847 ↗
  • 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. PubMed 18514825 ↗
  • 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. PubMed 17127126 ↗
  • 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. PubMed 20197533 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02574169
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Oct 12, 2015
Start date
Sep 1, 2016
Primary completion
May 16, 2022
Completion
May 16, 2022
Last update
Jun 1, 2026

Study contacts

Ségolène MROZEK, MD
principal investigator · UH TOULOUSE

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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