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HFCWO in Hospitalized Asthmatic Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hill-Rom
ClinicalTrials.gov Identifier:
NCT00722020
First received: July 23, 2008
Last updated: October 22, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention
Bronchial Asthma
Asthma
Status Asthmaticus
Device: VEST

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children

Further study details as provided by Hill-Rom:

Primary Outcome Measures:
  • The Primary Endpoint Will be Time to Readiness for Discharge. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Days in the hospital prior to patient being clinically ready to discharge


Secondary Outcome Measures:
  • Secondary Endpoint Total Hospital Length of Stay [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    Seconadary endpoint was Total Hospital length of stay


Enrollment: 43
Study Start Date: July 2008
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Hill-Rom Vest(tm)
No Intervention: Control
Historical control for PICU asthma patients

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.
  Eligibility

Ages Eligible for Study:   18 Months to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00722020

Locations
United States, New York
Winthrop University Hospital, Winthrop Pediatric Associates
Long Island, New York, United States, 11501
Winthrop University Hospital
Long Island, New York, United States, 11501
Sponsors and Collaborators
Hill-Rom
Investigators
Principal Investigator: Jon Roberts, MD Winthrop University
  More Information

Responsible Party: Hill-Rom
ClinicalTrials.gov Identifier: NCT00722020     History of Changes
Other Study ID Numbers: CR-0078 
Study First Received: July 23, 2008
Results First Received: August 25, 2015
Last Updated: October 22, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Hill-Rom:
Asthma
Bronchial Disease
Status Asthmaticus
High Frequency Chest Wall Oscillation
the Vest
HFCWO

Additional relevant MeSH terms:
Asthma
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 26, 2016