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

November 15, 2006 updated by: Hill-Rom

A Safety Study to Evaluate Intracranial Pressure With the Utilization of High Frequency Chest Wall Oscillation (HFCWO) Using the Vest™ on Mechanically Ventilated Neurosurgical Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas at Houston/Memorial Hermann Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Intracranial pressure
Heart rate
SpO2
Mean arterial pressure (MAP)
Arterial blood gases (ABGs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hill-Rom

Investigators

  • Principal Investigator: Robert L Levine, MD, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

January 17, 2006

First Submitted That Met QC Criteria

January 17, 2006

First Posted (Estimate)

January 19, 2006

Study Record Updates

Last Update Posted (Estimate)

November 16, 2006

Last Update Submitted That Met QC Criteria

November 15, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CR-0038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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