Status:
UNKNOWN
IRB-HSR# 14299: The Use of the Intrathoracic Pressure Regulator (ITPR) to Improve Cerebral Perfusion Pressure in Patients With Altered Intracranial Elastance
Lead Sponsor:
University of Virginia
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients who have a functioning intracranial pressure-monitoring device (either a subarachnoid bolt, or an intraventricular catheter) in place, and are either sedated, intubated, and mechanically vent...
Detailed Description
The ITPR is an FDA-approved device intended to increase circulation and blood pressure in hypovolemic and cardiogenic shock. The device is inserted within a standard respiratory circuit between the pa...
Eligibility Criteria
Inclusion
- 1\. patients who have a functioning intracranial pressure-monitoring device (either a subarachnoid bolt, or an intraventricular catheter) in place, and are either sedated, intubated, and mechanically ventilated (i.e. in the NNICU)and have an arterial line in place, or are scheduled to undergo an operation or interventional neuroradiological procedure at the University of Virginia.
- 2\. age 18 years of age and older 3. informed consent/ surrogate consent has been obtained
Exclusion
- 1\. pneumothorax 2. hemothroax 3. uncontrolled bleeding 4. uncontrolled hypertension defined as SBP \> 180 mmHg at the time of surgery 5. known respiratory disease such as chronic emphysema, COPD, or Cystic Fibrosis
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01205607
Start Date
May 1 2009
Last Update
September 20 2010
Active Locations (1)
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1
University of Virginia Health System
Charlottesville, Virginia, United States, 22908