HFCWO in Hospitalized Asthmatic Children

July 7, 2017 updated by: Hill-Rom

High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A historically controlled pilot study was conducted in pediatric patients 18 months to 18 years of age hospitalized with a diagnosis of asthma or reactive airway disease and admitted to the pediatric intensive care unit. Upon receiving informed consent, patients were treated with HFCWO therapy via the VEST. The primary endpoint was time to readiness for discharge, lack of need for continued supportive care (e.g., intravenous fluid or oxygen), and bronchodilator treatments spaced at least four hours apart.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Long Island City, New York, United States, 11501
        • Winthrop University Hospital, Winthrop Pediatric Associates
      • Long Island City, New York, United States, 11501
        • Winthrop University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vest Arm
HFCWO treatments 2-3 times daily 15 minutes per treatment via the VEST
Device: VEST
15 minutes of HFCWO via the Vest 2-3 times daily
Other Names:
  • Hill-Rom Vest(tm)
No Intervention: Control
Historical control for PICU asthma patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Primary Endpoint Will be Time to Readiness for Discharge.
Time Frame: 30 days
Days in the hospital prior to patient being clinically ready to discharge
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoint Total Hospital Length of Stay
Time Frame: 30 Days
Seconadary endpoint was Total Hospital length of stay
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hill-Rom

Investigators

  • Principal Investigator: Jon Roberts, MD, Winthrop University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 23, 2008

First Submitted That Met QC Criteria

July 24, 2008

First Posted (Estimate)

July 25, 2008

Study Record Updates

Last Update Posted (Actual)

August 7, 2017

Last Update Submitted That Met QC Criteria

July 7, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-0078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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