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

This study has been terminated.
Sponsor:
Information provided by:
Hill-Rom
ClinicalTrials.gov Identifier:
NCT00279097
First received: January 17, 2006
Last updated: November 15, 2006
Last verified: November 2006
  Purpose

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.


Condition Intervention
Intracranial Pressure
Device: High Frequency Chest Wall Oscillation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Hill-Rom:

Primary Outcome Measures:
  • Intracranial pressure
  • SpO2
  • Heart rate
  • Mean arterial pressure (MAP)
  • Arterial blood gases (ABGs)

Estimated Enrollment: 20
Study Start Date: January 2006
Estimated Study Completion Date: September 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279097

Locations
United States, Texas
University of Texas at Houston/Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hill-Rom
Investigators
Principal Investigator: Robert L Levine, MD University of Texas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00279097     History of Changes
Other Study ID Numbers: CR-0038
Study First Received: January 17, 2006
Last Updated: November 15, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Hill-Rom:
Intracranial pressure
High Frequency Chest Wall Oscillation
Neurosurgery

ClinicalTrials.gov processed this record on October 23, 2014