Respiratory Mechanics in Brain Injured Patients

Study Overview
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Brief Summary
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The hypothesis is that brain injury patients have alterations of the respiratory system related to intraabdominal pressure. Furthermore application of moderate levels of PEEP may improve respiratory function in these patients.

Detailed Description
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We investigate the mechanical properties of the respiratory system, partitioned into its lung and chest wall components, the functional residual capacity, the gas-exchange and alveolar recruitment in brain injured patients. The measurements will be performed under sedation at different levels of PEEP. The following groups will be included: a) control patients withot lung injury and brain injury; b) brain injured patients without lung injury within the first 72 hours; c) brain injured patients without lung injury after 72 hours; d) brain injured patients with lung injury. Brain injury was defined as primary or secondary. Respiratory functional data will be related to intra-abdominal pressure.

Official Title
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Effects of PEEP in Brain Injury Patients

Conditions
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Brain Injury, Acute Lung Injury

Intervention / Treatment
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* Other: PEEP
* Other: PEEP
* Other: PEEP
* Other: PEEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female Age > 18 yrs Mechanical ventilation No smoker No lung injury at entry Brain injury (traumatic or postoperative or spontaneous bleeding) in brain injury group Exclusion Criteria: Pregnancy Hemodynamic instability Immunodepression

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Patients without lung injury and brain injury | Other: PEEP<br>* Application of positive end expiratory pressure<br>* Other names: No brain injury No ALI;|
| Experimental: Brain No ALI 1<br>Patients with brain injury and no lung injury within 72 hours from ICU entry | Other: PEEP<br>* Application of positive end-expiratory pressure<br>* Other names: Brain No ALI 72hrs;|
| Experimental: Brain No ALI 2<br>Patients with brain injury and no ALI after 72 hours from ICU entry | Other: PEEP<br>* Application of positive end-expiratory pressure<br>* Other names: Brain NO ALI more 72 hrs;|
| Experimental: Brain ALI<br>Patients with brain injury and Acute Lung Injury (ALI) | Other: PEEP<br>* Application of positive end-expiratory pressure<br>* Other names: Brain and ALI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of respiratory function with PEEP |  | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relations of respiratory mechanics (lung and chest wall) with intraabdominal pressure |  | 30 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intraabdominal pressure