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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-09-30

Brief Summary

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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

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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.

Conditions

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Intracranial Pressure

Keywords

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Intracranial pressure High Frequency Chest Wall Oscillation Neurosurgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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High Frequency Chest Wall Oscillation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Robert L Levine, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

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University of Texas at Houston/Memorial Hermann Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CR-0038

Identifier Type: -

Identifier Source: org_study_id