Evaluation of High-Frequency Chest Wall Oscillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hill-Rom
ClinicalTrials.gov Identifier:
NCT00717873
First received: July 1, 2008
Last updated: March 20, 2012
Last verified: March 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Enrollment: 330
Study Start Date: June 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HFCWO Arm
Airway clearance provided by the Vest Airway Clearance System
Device: Airway clearance
Provided by the Vest Airway clearance system
Active Comparator: CPT Arm
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
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: NCT00717873

Locations
United States, Missouri
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Hill-Rom
Investigators
Principal Investigator: Darnetta Clinkscale, RRT Barnes-Jewish Hospital
  More Information

No publications provided by Hill-Rom

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT00717873     History of Changes
Other Study ID Numbers: CR-0080
Study First Received: July 1, 2008
Last Updated: March 20, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014