Status:
TERMINATED
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
Lead Sponsor:
Advanced Circulatory Systems
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Head Injury
Eligibility:
All Genders
15+ years
Phase:
PHASE4
Brief Summary
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) an...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01824589
Start Date
August 1 2012
Last Update
February 16 2015
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