Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion

Not Applicable

Terminated

Conditions: Head Injury
Intracranial Pathology
Compromised Cerebral Perfusion

Interventions: Device: ITPR

Registration Number: NCT01824576

Lead Sponsor: Advanced Circulatory Systems

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 9

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ITPR	ITPR	Use of the ITPR for 120 minutes.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Cerebral Perfusion Pressure (CPP)	During 120 minutes of device use	Change from average baseline CPP compared with the average CPP during use of the ITPR.

Secondary Outcome Measures

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