Status:
TERMINATED
Effect of Intrathoracic Pressure Regulation on Decreased Cerebral Perfusion
Lead Sponsor:
Advanced Circulatory Systems
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Head Injury
Intracranial Pathology
Eligibility:
All Genders
18+ years
Phase:
NA
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 evalu...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01824576
Start Date
April 1 2013
End Date
November 1 2016
Last Update
September 27 2017
Active Locations (2)
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1
Denver
Denver, Colorado, United States
2
Baltimore
Baltimore, Maryland, United States