Intracranial Pressure
Conditions
Keywords
Intracranial pressure, High Frequency Chest Wall Oscillation, Neurosurgery
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 subjects.
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 pressure monitors having normal opening pressures and ICP less than or equal to 20 mmHg. The secondary objective of this study is to evaluate changes in arterial blood gases that may result with Vest™ therapy in ventilated patients.
Interventions
Sponsors
Hill-Rom
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial pressure | — |
| SpO2 | — |
| Heart rate | — |
| Mean arterial pressure (MAP) | — |
| Arterial blood gases (ABGs) | — |
Countries
United States
Outcome results
None listed