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HFCWO in Hospitalized Asthmatic Children

H

Hill-Rom

Status

Completed

Conditions

Asthma
Bronchial Asthma
Status Asthmaticus

Treatments

Device: VEST

Study type

Interventional

Funder types

Industry

Identifiers

NCT00722020
CR-0078

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

18 months to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

43 participants in 2 patient groups

Vest Arm
Experimental group
Description:
HFCWO treatments 2-3 times daily 15 minutes per treatment via the VEST
Treatment:
Device: VEST
Control
No Intervention group
Description:
Historical control for PICU asthma patients

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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