Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation

NCT02574169 | Recruiting DMC

• 1 other identifier: RC31/15/7604
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 5

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.

Conditions

Cerebral Injuries; Acute Respiratory Distress Syndrome (ARDS)

Keywords

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

Outcome Measures

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

  60 minutes

Secondary Outcomes (8)

• Comparison of systemic hemodynamic parameters

  60 minutes

• Comparison of Intracranial hemodynamic parameters

  60 minutes

• Comparison of blood oxygen level

  60 minutes

• Comparison of partial pressure of carbon dioxide

  60 minutes

• Comparison of arterial blood gases

  60 minutes

Study Arms (2)

Alveolar recruitment maneuvers Group 1

EXPERIMENTAL

alveolar recruitment maneuvers by CPAP then alveolar recruitment maneuvers by eSigh

Other: alveolar recruitment maneuvers group 1

Alveolar recruitment maneuvers Group 2

EXPERIMENTAL

alveolar recruitment maneuvers by eSigh then alveolar recruitment maneuvers by CPAP

Other: alveolar recruitment maneuvers group 2

Interventions

alveolar recruitment maneuvers group 1 OTHER

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 1

alveolar recruitment maneuvers group 2 OTHER

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.

Alveolar recruitment maneuvers Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (5)

UH Toulouse

Toulouse, Midi Pyrénées, 31059, France

RECRUITING

UH Caen

Caen, 140033, France

RECRUITING

UH Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

UH Montpellier

Montpellier, 34295, France

RECRUITING

UH Nantes

Nantes, 44093, France

RECRUITING

Related Publications (4)

• 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.

  PMID: 18416847 BACKGROUND

• 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.

  PMID: 18514825 BACKGROUND

• 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.

  PMID: 17127126 BACKGROUND

• 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.

  PMID: 20197533 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Ségolène MROZEK, MD

  UH TOULOUSE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ségolène MROZEK, MD

CONTACT

05 61 77 21 67; mrozek.s@chu-toulouse.fr

Audrey Tomasik

CONTACT

05 61 77 85 97; tomasik.a@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2015
• First Posted: October 12, 2015
• Study Start: September 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

FR (5)