Safety Study to Evaluate Intracranial Pressure During High Frequency Chest Wall Oscillation

Stopped early · Not applicable

Conditions studied: Intracranial Pressure

In brief

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.

Key facts

Study ID

NCT00279097

Run by

Hill-Rom

People needed

20

Starts

2006-01-01

Expected to finish

2006-09-01

Last updated by the study team

2006-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Texas at Houston/Memorial Hermann Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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