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

Hill-Rom20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Intracranial Pressure

Interventions

High Frequency Chest Wall OscillationDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Texas at Houston/Memorial Hermann Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

Intracranial pressure

SpO2

Heart rate

Mean arterial pressure (MAP)

Arterial blood gases (ABGs)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.