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Evaluation of High-Frequency Chest Wall Oscillation
This study is currently recruiting participants.
Verified by Hill-Rom, June 2009
First Received: July 1, 2008   Last Updated: June 19, 2009   History of Changes
Sponsored by: Hill-Rom
Information provided by: Hill-Rom
ClinicalTrials.gov Identifier: NCT00717873
  Purpose

To compare the outcomes of patients treated with the Vest and conventional chest physiotherapy to determine if the Vest provides equivalent therapy


Condition Intervention Phase
Airway Secretion Clearance
Device: Airway clearance
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Evaluation of High-Frequency Chest Wall Oscillation Using the Vest Airway Clearance System Compared to Conventional Chest Physical Therapy at Barnes-Jewish Hospital

Further study details as provided by Hill-Rom:

Primary Outcome Measures:
  • Hospital Length of Stay [ Time Frame: Discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU Length of Stay [ Time Frame: Discharge ] [ Designated as safety issue: No ]
  • Days of Mechanical Ventilation [ Time Frame: Discharge ] [ Designated as safety issue: No ]
  • Days to resolution of atelectasis [ Time Frame: Discharge ] [ Designated as safety issue: No ]
  • Days of CPT required [ Time Frame: Discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: June 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HFCWO Arm: Experimental
Airway clearance provided by the Vest Airway Clearance System
Device: Airway clearance
Provided by the Vest Airway clearance system
CPT Arm: Active Comparator
Airway clearance provided by manual CPT
Device: Airway clearance
Airway clearance provided by manual CPT

  Eligibility

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

Inclusion Criteria:

  • Acute or chronic disease requiring secretion mobilization as per hospital protocol

Exclusion Criteria:

  • Absolute contraindications for positional changes
  • Absolute contraindications for chest percussion
  • Women visibly pregnant
  • Previous enrollment in study
  • Previous CPT or Vest treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717873

Contacts
Contact: Darnetta Clinkscale, MBA, RRT 314.362.1276 mdb3455@bjc.org

Locations
United States, Missouri
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Darnetta Clinkscale, RRT     314-362-1276        
Principal Investigator: Darneta Clinkscale, RRT            
Sponsors and Collaborators
Hill-Rom
Investigators
Principal Investigator: Darnetta Clinkscale, RRT Barnes-Jewish Hospital Foundation
  More Information

No publications provided

Responsible Party: Hill-Rom ( Gordon MacFarlane, PhD, Director of Clinical Research )
Study ID Numbers: CR-0080
Study First Received: July 1, 2008
Last Updated: June 19, 2009
ClinicalTrials.gov Identifier: NCT00717873     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Hill-Rom:
Mucus Clearance
Secretion Clearance
HFCWO

ClinicalTrials.gov processed this record on September 10, 2009