- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01159392
Alveolar Recruitment in Brain Injury
Effects of Recruitment Maneuvers in Patients With Acute Brain Injury and Acute Lung Injury
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Barcelona, Spain, 08036
- Trauma and Surgical ICU, Hospital Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Brain injury plus acute lung injury
Patients with severe brain injury (Glasgow coma score<13) with acute lung injury (PaO2/FiO2 <300 mmHg)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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arterial oxygenation
Time Frame: 8 hours
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Arterial oxygenation was expressed as PaO2/FiO2 ratio
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8 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cerebral hemodynamics
Time Frame: 8 hours
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Cerebral hemodynamics will be assessed by cerebral perfusion pressure and intracranial pressure
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8 hours
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elizabeth Zavala, MD, PhD, Hospital Clinic, Barcelona, Spain
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RM-0152
- FIS-0152 (Other Grant/Funding Number: Fondo de Investigaciones Sanitarias)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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