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临床试验/NCT00722020
NCT00722020已完成不适用

High Frequency Chest Wall Oscillation in Hospital Management of Asthmatic Children

Hill-Rom4 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2008年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
4
主要终点
The Primary Endpoint Will be Time to Readiness for Discharge.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Vest Arm

Experimental

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

干预措施: VEST (Device)

Control

No Intervention

Historical control for PICU asthma patients

结局指标

主要结局

The Primary Endpoint Will be Time to Readiness for Discharge.

时间窗: 30 days

Days in the hospital prior to patient being clinically ready to discharge

次要结局

  • Secondary Endpoint Total Hospital Length of Stay(30 Days)

研究者

发起方
Hill-Rom
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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