Alveolar Recruitment in Brain Injury

This study has been completed.
Sponsor:
Collaborator:
Fondo de Investigacion Sanitaria
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01159392
First received: July 8, 2010
Last updated: NA
Last verified: February 2001
History: No changes posted
  Purpose

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
Brain Injury
Acute Lung Injury

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Recruitment Maneuvers in Patients With Acute Brain Injury and Acute Lung Injury

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • arterial oxygenation [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Arterial oxygenation was expressed as PaO2/FiO2 ratio


Secondary Outcome Measures:
  • cerebral hemodynamics [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
    Cerebral hemodynamics will be assessed by cerebral perfusion pressure and intracranial pressure


Enrollment: 9
Study Start Date: February 2001
Study Completion Date: November 2003
Groups/Cohorts
Brain injury plus acute lung injury
Patients with severe brain injury (Glasgow coma score<13) with acute lung injury (PaO2/FiO2 <300 mmHg)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159392

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

No publications provided

Responsible Party: Elizabeth Zavala, Hospital Clinic
ClinicalTrials.gov Identifier: NCT01159392     History of Changes
Other Study ID Numbers: RM-0152, FIS-0152
Study First Received: July 8, 2010
Last Updated: July 8, 2010
Health Authority: Spain: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 24, 2014