Alveolar Recruitment in Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01159392
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : July 9, 2010
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Clinic of Barcelona

Brief Summary:
Development of acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) in patients with severe brain injury has been associated with poor outcome. The application of lung recruitment maneuvers (RM) for a short period of time to open collapsed alveoli and reverse hypoxemia in early ARDS has been recommended. However, little is known about the cerebral and vascular effects of RM in brain injury patients with ALI/ARDS. The aim of this study is to assess the effects of a single standardized RM on oxygenation and on systemic and cerebral hemodynamics in severe brain injury patients with ALI/ARDS.

Condition or disease
Brain Injury Acute Lung Injury

Detailed Description:

Patients with severe brain injury comprise a significant portion of admissions to critical care units. These patients are unable to adequately protect their airways and are usually intubated and mechanically ventilated. The goal of mechanical ventilation in patients with brain injury is to optimize blood gas exchange while minimizing intrathoracic pressure to avoid interference with cerebral venous drainage.Over the last 20 years, a plethora of experimental and clinical data have shown that mechanical ventilation can cause or aggravate lung damage in patients with acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS). The aim of this pilot study was to assess the effects of a single standardized recruitment maneuver (RM) on oxygenation and on systemic and cerebral hemodynamics in severe brain injury patients with ALI/ARDS.

Only patients with brain injury, as defined by a Glasgow Coma Score <13, admitted into the Trauma and Surgical intensive care unit (ICU) will be studied.

After obtaining informed consent, a RM will be performed by switching the ventilator from assist/control ventilation to continuous positive airway pressure (CPAP) and applying a pressure of 40 cmH2O for 40 sec (11). After the RM, patients have been ventilated in pressure control ventilation and PEEP will be gradually reduced in decremental steps every 3 respiratory cycles starting with PEEP at 30 cm H2O, maintaining a maximum peak pressure of 40 cmH2O during this procedure until pre-RM PEEP levels are achieved. The RM will be discontinued if any of the following changes developed during the procedure: (i) ≥20% changes in baseline systemic blood pressure, (ii) ICP ≥20 mmHg, or (iii) SaO2 ≤90%. After the RM is performed, respiratory mechanics, arterial and SjO2 blood samples and systemic and cerebral hemodynamics will be obtained at 30 min and 8 hours.

Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Recruitment Maneuvers in Patients With Acute Brain Injury and Acute Lung Injury
Study Start Date : February 2001
Actual Study Completion Date : November 2003

Brain injury plus acute lung injury
Patients with severe brain injury (Glasgow coma score<13) with acute lung injury (PaO2/FiO2 <300 mmHg)

Primary Outcome Measures :
  1. arterial oxygenation [ Time Frame: 8 hours ]
    Arterial oxygenation was expressed as PaO2/FiO2 ratio

Secondary Outcome Measures :
  1. cerebral hemodynamics [ Time Frame: 8 hours ]
    Cerebral hemodynamics will be assessed by cerebral perfusion pressure and intracranial pressure

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with brain injury (Glasgow Coma Score<13) admitted into the Trauma and Surgical Intensive care unit (ICU) at the Hospital Clinic, Barcelona.

Inclusion Criteria:

  • Patients with brain injury who met the ALI/ARDS criteria within 72 hours after ICU admission

Exclusion Criteria:

  • <18 years of age
  • Cardiogenic edema
  • Hemodynamic instability
  • Intracranial hypertension

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01159392

Trauma and Surgical ICU, Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Fondo de Investigacion Sanitaria
Principal Investigator: Elizabeth Zavala, MD, PhD Hospital Clinic, Barcelona, Spain

Responsible Party: Elizabeth Zavala, Hospital Clinic Identifier: NCT01159392     History of Changes
Other Study ID Numbers: RM-0152
FIS-0152 ( Other Grant/Funding Number: Fondo de Investigaciones Sanitarias )
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: July 9, 2010
Last Verified: February 2001

Keywords provided by Hospital Clinic of Barcelona:
brain injury
mechanical ventilation
acute lung injury
lung recruitment

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Respiration Disorders