NCT00279097

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

November 16, 2006

Status Verified

November 1, 2006

First QC Date

January 17, 2006

Last Update Submit

November 15, 2006

Conditions

Intracranial Pressure

Keywords

Intracranial pressureHigh Frequency Chest Wall OscillationNeurosurgery

Outcome Measures

Primary Outcomes (5)

  • Intracranial pressure

  • SpO2

  • Heart rate

  • Mean arterial pressure (MAP)

  • Arterial blood gases (ABGs)

Interventions

High Frequency Chest Wall OscillationDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Houston/Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Chest Wall Oscillation

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Study Officials

  • Robert L Levine, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 17, 2006

First Posted

January 19, 2006

Study Start

January 1, 2006

Study Completion

September 1, 2006

Last Updated

November 16, 2006

Record last verified: 2006-11

Locations

US(1)