Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation
NCT ID: NCT02574169
Last Updated: 2024-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2016-09-01
2025-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Alveolar recruitment maneuvers Group 1
alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh
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.
Alveolar recruitment maneuvers Group 2
alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Patients with moderate and severe ARDS criteria (as defined by classification of Berlin)
* Patients under mechanical ventilation
Exclusion Criteria
* Pregnant women
* Patients with history of chronic respiratory disease
* Patients with bronchopleural fistula
* Patients with hemodynamic instability despite appropriate measures
18 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Ségolène MROZEK, MD
Role: PRINCIPAL_INVESTIGATOR
UH TOULOUSE
Locations
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UH Toulouse
Toulouse, Midi Pyrénées, France
UH Caen
Caen, , France
UH Clermont-Ferrand
Clermont-Ferrand, , France
UH Montpellier
Montpellier, , France
UH Nantes
Nantes, , France
Countries
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Central Contacts
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Facility Contacts
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Ségolène MROZEK, MD
Role: backup
Thomas GEERAERTS, MD
Role: backup
Béatrice RIU, MD
Role: backup
References
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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.
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.
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.
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.
Other Identifiers
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RC31/15/7604
Identifier Type: -
Identifier Source: org_study_id
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