Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation

Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

— M'RHICO  

Official title:

Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02574169
• Other study ID #: RC31/15/7604
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Ségolène MROZEK, MD
• Phone: 05 61 77 21 67
• Email: mrozek.s[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Brain Injuries
• Cerebral Injuries
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	UH Caen	Caen
France	UH Clermont-Ferrand	Clermont-Ferrand
France	UH Montpellier	Montpellier
France	UH Nantes	Nantes
France	UH Toulouse	Toulouse	Midi Pyrénées

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	60 minutes
Secondary	Comparison of systemic hemodynamic parameters	Comparison between the two ARM of systemic hemodynamic parameters: mean arterial pressure, heart rate and cardiac output.	60 minutes
Secondary	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)	60 minutes
Secondary	Comparison of blood oxygen level	Comparison between the two ARM of haematosis: Blood oxygen level (SpO2)	60 minutes
Secondary	Comparison of partial pressure of carbon dioxide	Comparison between the two ARM of partial pressure of carbon dioxide (PaCO2),	60 minutes
Secondary	Comparison of arterial blood gases	Comparison between the two ARM of arterial blood gases (partial pressure of oxygen (PaO2),	60 minutes
Secondary	Comparison of end-tidal CO2	Comparison between the two ARM of end-tidal CO2	60 minutes
Secondary	Comparison of Respiratory parameters	Comparison between the two ARM of Respiratory parameters: plateau pressure and static lung compliance.	60 minutes
Secondary	Comparison of PtiO2	Comparison between the two ARM of PtiO2	60 minutes