Alveolar Recruitment in Brain Injury

Acute Lung Injury Clinical Trial

Official title:

Effects of Recruitment Maneuvers in Patients With Acute Brain Injury and Acute Lung Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159392
• Other study ID #: RM-0152
• Secondary ID: FIS-0152
• Status: Completed
• Phase: N/A
• First received: July 8, 2010
• Last updated: July 8, 2010
• Start date: February 2001
• Est. completion date: November 2003

Study information

• Verified date: February 2001
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Brain Injuries
• Brain Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult

Locations

Country	Name	City	State
Spain	Trauma and Surgical ICU, Hospital Clinic	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Fondo de Investigacion Sanitaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arterial oxygenation	Arterial oxygenation was expressed as PaO2/FiO2 ratio	8 hours	No
Secondary	cerebral hemodynamics	Cerebral hemodynamics will be assessed by cerebral perfusion pressure and intracranial pressure	8 hours	No