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

Hill-Rom

Status: Terminated

Conditions: Intracranial Pressure

Treatments: Device: High Frequency Chest Wall Oscillation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00279097

CR-0038

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)