HFCWO in Hospitalized Asthmatic Children

Asthma Clinical Trial

Official title:

High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722020
• Other study ID #: CR-0078
• Status: Completed
• Phase: N/A
• First received: July 23, 2008
• Last updated: October 22, 2015
• Start date: July 2008
• Est. completion date: July 2010

Study information

• Verified date: October 2015
• Source: Hill-Rom
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma
• Status Asthmaticus

Intervention

Device:
• VEST
15 minutes of HFCWO via the Vest 2-3 times daily

Locations

Country	Name	City	State
United States	Winthrop University Hospital	Long Island	New York
United States	Winthrop University Hospital, Winthrop Pediatric Associates	Long Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Endpoint Will be Time to Readiness for Discharge.	Days in the hospital prior to patient being clinically ready to discharge	30 days	No
Secondary	Secondary Endpoint Total Hospital Length of Stay	Seconadary endpoint was Total Hospital length of stay	30 Days	No