Status:
TERMINATED
Safety Study to Evaluate Intracranial Pressure During High Frequency Chest Wall Oscillation
Lead Sponsor:
Hill-Rom
Conditions:
Intracranial Pressure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate changes in intracranial pressure (ICP) during or immediately following high frequency chest wall oscillation (HFCWO) treatment with the Vest™ in neurosurgical ...
Detailed Description
This study is a single site safety study to evaluate changes in intracranial pressure during or immediately following HFCWO treatment with the Vest™ in neurosurgical subjects with intracranial pressur...
Eligibility Criteria
Inclusion
- ICP monitor with normal opening pressure (greater than or equal to 20 mmHg)
- On ventilator
- Arterial line in place
- Age equal to or greater than 18
- Admitted to neurotrauma intensive care unit (ICU)
Exclusion
- Inability to obtain informed consent
- Unstable spinal cord injury
- ICP \> 20 mmHg sustained for \> 5 minutes
- Hemodynamic instability within the prior 12 hours
- Active hemoptysis
- Hemothorax
- New onset, unstable arrhythmia
- Enrollment in another interventional study
- Aneurysm that has not been clipped or coiled
- Coagulopathic head injury subjects
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00279097
Start Date
January 1 2006
End Date
September 1 2006
Last Update
November 16 2006
Active Locations (1)
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1
University of Texas at Houston/Memorial Hermann Hospital
Houston, Texas, United States, 77030