Alveolar Recruitment in Brain Injury

NCT ID: NCT01159392

Last Updated: 2010-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2003-11-30

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.

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.

Conditions

Brain Injury; Acute Lung Injury

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Brain injury plus acute lung injury

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondo de Investigacion Sanitaria

OTHER

Sponsor Role: collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Hospital Clinic

Principal Investigators

Elizabeth Zavala, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic, Barcelona, Spain

Locations

Trauma and Surgical ICU, Hospital Clinic

Barcelona, , Spain

Countries

Spain

Other Identifiers

FIS-0152

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RM-0152

Identifier Type: -

Identifier Source: org_study_id