HFCWO in Hospitalized Asthmatic Children

Not Applicable

Completed

• Conditions: Asthma; Status Asthmaticus; Bronchial Asthma
• Interventions: Device: VEST

• Registration Number: NCT00722020
• Lead Sponsor: Hill-Rom

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.

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-25
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Results First Submitted: 2015-08-25
• Results First Submitted QC: 2015-10-22
• Results First Posted: 2015-11-24
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-07
• Last Update Posted: 2017-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vest Arm	VEST	HFCWO treatments 2-3 times daily 15 minutes per treatment via the VEST

Primary Outcome Measures

Name	Time	Method
The Primary Endpoint Will be Time to Readiness for Discharge.	30 days	Days in the hospital prior to patient being clinically ready to discharge

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint Total Hospital Length of Stay	30 Days	Seconadary endpoint was Total Hospital length of stay

Trial Locations

Locations (2)

Winthrop University Hospital; 🇺🇸 Long Island City, New York, United States

Winthrop University Hospital, Winthrop Pediatric Associates; 🇺🇸 Long Island City, New York, United States