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Clinical Trials/NCT00279097
NCT00279097
Terminated
Not Applicable

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

Hill-Rom1 site in 1 country20 target enrollmentJanuary 2006
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ConditionsIntracranial Pressure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracranial Pressure
Sponsor
Hill-Rom
Enrollment
20
Locations
1
Primary Endpoint
Intracranial pressure
Status
Terminated
Last Updated
19 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
September 2006
Last Updated
19 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hill-Rom

Eligibility 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

Outcomes

Primary Outcomes

Intracranial pressure

SpO2

Heart rate

Mean arterial pressure (MAP)

Arterial blood gases (ABGs)

Study Sites (1)

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