Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the physiological response to application of the Intrathoracic Pressure Regulator (ITPR) in patients with compromised cerebral circulation. The study will evaluate the physiological response to intrathoracic pressure regulation (IPR) therapy in hemodynamically stable patients with compromised cerebral circulation who are on ventilatory support.

Official Title
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Physiological Effects of Intrathoracic Pressure Regulation in Patients With Decreased Cerebral Perfusion Due to Brain Injury or Intracranial Pathology

Conditions
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Head Injury, Intracranial Pathology, Compromised Cerebral Perfusion

Intervention / Treatment
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* Device: ITPR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age intubated and mechanically ventilated on a volume controlled mode head injury or other intracranial pathology and compromised cerebral perfusion arterial line in place or alternative with continuous pressure monitoring SpO2 ≥90% mean arterial pressure >55 admission to ICU or about to undergo neurosurgery with planned placement of an invasive intracranial pressure monitor inclusion presents no significant delays to planned emergent neurosurgery prior written informed consent Exclusion Criteria: cardiac or pulmonary injury confirmed pneumothorax or hemothorax 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 marked hypertension at time of device use defined as systolic blood pressure >180 mmHg congestive heart failure women with positive serum or urine pregnancy test or breast feeding

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITPR<br>Use of the ITPR for 120 minutes. | Device: ITPR<br>* Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations.<br>* Other names: CirQlator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Cerebral Perfusion Pressure (CPP) | Change from average baseline CPP compared with the average CPP during use of the ITPR. | During 120 minutes of device use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Systolic Blood Pressure (SBP) | Measure change in systolic blood pressure average during baseline and 15 minutes following removal of the ITPR | baseline to15 minutes following device use | 
| Change From Baseline in PaCO2 | PaCO2 will be collected during baseline and 15 minutes after device activation and change will be evaluated. | baseline and 15 minutes after device activation | 
| Change From Baseline in Diastolic Blood Pressure (DBP) | Measure change in diastolic blood pressure average during baseline and 15 minutes following removal of the ITPR | baseline to 15 minutes following device use | 
| Change From Baseline in Mean Arterial Pressure (MAP) | Measure change in mean arterial pressure average during baseline and 15 minutes following removal of the ITPR | baseline to 15 minutes following device use | 
| Change From Baseline in Heart Rate (HR) | Measure change in heart rate average during baseline and 15 minutes following removal of the ITPR | baseline to 15 minutes following device use | 
| Change From Baseline in Pulse Pressure (PP) | Measure change in pulse pressure average during baseline and 15 minutes following removal of the ITPR | baseline to 15 minutes following device use | 
| Change From Baseline in End-tidal Carbon Dioxide (EtCO2) | Measure change in EtCO2 average during baseline and 15 minutes following removal of the ITPR | baseline to 15 minutes following device use | 
| Change From Baseline in Oxygen Saturation (SpO2) | Measure change in SpO2 average during baseline and 15 minutes following removal of the ITPR | basseline to 15 minutes following device use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ITPR, CPP, TBI, traumatic brain injury, cerebral perfusion pressure, intrathoracic pressure regulator