HFCWO in Hospitalized Asthmatic Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bronchial Asthma Asthma Status Asthmaticus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Vest Arm

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

Group Type EXPERIMENTAL

VEST

Intervention Type DEVICE

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

Control

Historical control for PICU asthma patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VEST

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

Intervention Type DEVICE

Other Intervention Names

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Hill-Rom Vest(tm)

Eligibility Criteria

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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

Minimum Eligible Age

18 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No