Clinical trial NCT02574169: Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation
Official title: Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Injuries
Acute Respiratory Distress Syndrome (ARDS)
Keywords: Alveolar Recruitment Maneuvers (ARM)
Continuous Positive Airway Pressure (CPAP)
Extended Sigh (eSigh)
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Comparison of oxygen tissue partial pressure (PtiO2) values
timeFrame: 60 minutes
Secondary outcomes:
measure: Comparison of systemic hemodynamic parameters
timeFrame: 60 minutes
measure: Comparison of Intracranial hemodynamic parameters
timeFrame: 60 minutes
measure: Comparison of blood oxygen level
timeFrame: 60 minutes
measure: Comparison of partial pressure of carbon dioxide
timeFrame: 60 minutes
measure: Comparison of arterial blood gases
timeFrame: 60 minutes
measure: Comparison of end-tidal CO2
timeFrame: 60 minutes
measure: Comparison of Respiratory parameters
timeFrame: 60 minutes
measure: Comparison of PtiO2
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UH Toulouse
state: Midi Pyrénées
city: Caen
country: France
facility: UH Caen
city: Clermont-Ferrand
country: France
facility: UH Clermont-Ferrand
city: Montpellier
country: France
facility: UH Montpellier
city: Nantes
country: France
facility: UH Nantes
Study officials:
affiliation: UH TOULOUSE
name: Ségolène MROZEK, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.