NCT00722020

Brief Summary

To determine whether or not high frequency chest wall oscillation (in the form of the VestTM) is superior to regular asthma therapy in the management of children hospitalized with moderate to severe asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

July 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

November 24, 2015

Completed
Last Updated

August 7, 2017

Status Verified

July 1, 2017

Enrollment Period

1.9 years

First QC Date

July 23, 2008

Results QC Date

August 25, 2015

Last Update Submit

July 7, 2017

Conditions

Bronchial AsthmaAsthmaStatus Asthmaticus

Keywords

AsthmaBronchial DiseaseStatus AsthmaticusHigh Frequency Chest Wall Oscillationthe VestHFCWO

Outcome Measures

Primary Outcomes (1)

  • The Primary Endpoint Will be Time to Readiness for Discharge.

    Days in the hospital prior to patient being clinically ready to discharge

    30 days

Secondary Outcomes (1)

  • Secondary Endpoint Total Hospital Length of Stay

    30 Days

Study Arms (2)

Vest Arm

EXPERIMENTAL

HFCWO treatments 2-3 times daily 15 minutes per treatment via the VEST

Device: VEST

Control

NO INTERVENTION

Historical control for PICU asthma patients

Interventions

VESTDEVICE

15 minutes of HFCWO via the Vest 2-3 times daily

Also known as: Hill-Rom Vest(tm)
Vest Arm

Eligibility Criteria

Age18 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Any pediatric patient between the ages of 18 months and 18 years admitted to Winthrop University Hospital's pediatric floor or intensive care unit with a diagnosis of asthma or reactive airway disease

You may not qualify if:

  • Patients with chronic, comorbid respiratory conditions (e.g., cerebral palsy, cystic fibrosis)
  • Those who regularly use HFCWO
  • Any patient exhibiting an absolute contraindication to HFCWO therapy
  • Absolute contraindications to using HFCWO include head and neck injury prior to stabilization, and active hemorrhage with hemodynamic instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Winthrop University Hospital, Winthrop Pediatric Associates

Long Island City, New York, 11501, United States

Location

Winthrop University Hospital

Long Island City, New York, 11501, United States

Location

MeSH Terms

Conditions

AsthmaStatus AsthmaticusBronchial Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Jon Roberts, MD
Organization
Winthrop University
jroberts@winthrop.org
516-663-4600

Study Officials

  • Jon Roberts, MD

    Winthrop University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

July 1, 2008

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

August 7, 2017

Results First Posted

November 24, 2015

Record last verified: 2017-07

Locations

US(2)