NCT00717873

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2008

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 18, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

September 25, 2015

Completed
Last Updated

August 7, 2017

Status Verified

July 1, 2017

Enrollment Period

2.5 years

First QC Date

July 1, 2008

Results QC Date

August 25, 2015

Last Update Submit

July 7, 2017

Conditions

Airway Secretion Clearance

Keywords

Mucus ClearanceSecretion ClearanceHFCWO

Outcome Measures

Primary Outcomes (1)

  • Hospital Length of Stay

    an average of 10 days

    Admission to Discharge

Study Arms (2)

HFCWO Arm

EXPERIMENTAL

Airway clearance provided by the Vest Airway Clearance System

Device: Airway clearance Device

CPT Arm

NO INTERVENTION

Airway clearance provided by manual CPT

Interventions

Airway clearance DeviceDEVICE

Provided by the Vest Airway clearance system

HFCWO Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Absolute contraindications for positional changes
  • Absolute contraindications for chest percussion
  • Women visibly pregnant
  • Previous enrollment in study
  • Previous CPT or Vest treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

  • Morrison L, Milroy S. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Apr 30;4(4):CD006842. doi: 10.1002/14651858.CD006842.pub5.

    PMID: 32352564DERIVED

  • Clinkscale D, Spihlman K, Watts P, Rosenbluth D, Kollef MH. A randomized trial of conventional chest physical therapy versus high frequency chest wall compressions in intubated and non-intubated adults. Respir Care. 2012 Feb;57(2):221-8. doi: 10.4187/respcare.01299. Epub 2011 Jul 12.

    PMID: 21762564DERIVED

Results Point of Contact

Title
Darnetta Clinkscale
Organization
Barnes Jewish Hospital
MDB3455@bjc.org
(314) 362-1276

Study Officials

  • Darnetta Clinkscale, RRT

    Barnes-Jewish Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 18, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 7, 2017

Results First Posted

September 25, 2015

Record last verified: 2017-07

Locations

US(1)