Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).

Official Title
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Effects of Intrathoracic Pressure Regulation Therapy in Patients With Elevated Intracranial Pressure Due to Brain Injury or Intracranial Pathology

Conditions
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Head Injury

Intervention / Treatment
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* Device: -7 cm H2O ITPR
* Device: -12cm H2O ITPR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥15 years of age intubated and mechanically ventilated on a volume controlled mode head injury or other intracranial pathology with ICP of ≥15 mmHg arterial line in place SpO2 ≥95% MAP >60 in ICU or about to undergo neurosurgery with planned placement of an ICP monitor inclusion presents no significant delays to planned emergent neurosurgery prior written informed consent Exclusion Criteria: cardiac or pulmonary injury impacting intrathoracic pressure confirmed pneumothorax or hemothorax PaO2/FiO2 <300 serious neck injury resulting in neck swelling with jugular venous compression evidence of ongoing uncontrolled bleeding respiratory disease such as COPD, interstitial lung disease, or other parenchymal or pulmonary vascular disease congestive heart failure

Ages Eligible for Study
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Minimum Age: 15 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device | Device: -7 cm H2O ITPR<br>* Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations.<br>* Other names: Intrathoracic Pressure Regulator, CirQlator;|
| Active Comparator: Group B<br>tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device | Device: -7 cm H2O ITPR<br>* Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations.<br>* Other names: Intrathoracic Pressure Regulator, CirQlator;|
| Active Comparator: Group C<br>tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device | Device: -12cm H2O ITPR<br>* Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations.<br>* Other names: Intrathoracic Pressure Regulatory, CirQlator;|
| Active Comparator: Group D<br>tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device | Device: -12cm H2O ITPR<br>* Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations.<br>* Other names: Intrathoracic Pressure Regulatory, CirQlator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intracranial Pressure (ICP) | Change in ICP from baseline will be compared with the ICP during 15 minutes of ITPR use. | 15 minutes after device is activated | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Perfusion Pressure (CPP) | Measurement of the difference between baseline CPP and CPP at 15 minutes | 15 minutes after device activation | 
| Lung Compliance | Change in lung compliance following each ITPR treatment compared to baseline. | baseline and immediately after device removal | 
| Arterial Blood Gases (PaCO2) | Arterial blood gases will be collected. | 15 minutes after device activation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury, TBI, ITPR, intrathoracic pressure regulator, hepatic encephalopathy, pseudotumorcerebri, obstructive hydrocephalus, intracranial hemorrhage