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临床试验/NCT03666429
NCT03666429撤回不适用

Effectiveness of the NoseFrida Compared With Bulb Suction at Relieving Objective Signs of Nasal Obstruction and Reducing Return Visits in Pediatric Patients Presenting to the Emergency Department

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Parental satisfaction

研究概览

简要总结

The mainstay of treatment in viral upper and lower respiratory tract disease is airway clearance. Viral respiratory tract infections account for a substantial amount of emergency department (ED) visits, financial and stress burden on caregivers. In addition, they also account for a large number of ED return visits. While airway clearance is considered a mainstay of treatment the pragmatic effectiveness of various devices remain unstudied in patients who are discharged from the ED.

The objectives of this study are to compare the pragmatic effectiveness of two commonly used suction devices the NoseFrida and bulb suction and to provide a descriptive analysis on 72 hour return to ED rates and readmission rates. Patients will be enrolled October 15, 2018 to October 15, 2019 or until NoseFrida supplies are depleted. Fridababy will supply 500 NoseFrida devices and replacement filters. Patients aged 1 day to 24 months presenting Vanderbilt Childrens ED with symptoms of nasal congestion or bronchiolitis who require suctioning and will be discharged from the ED will be approached for enrollment. Exclusion criteria include no upper airway abnormalities or previously enrolled in study. The study design is a prospective and retrospective observational study. We anticipate about 500 patients to be enrolled in this study. Families will then be approached for consent to participate. Caregiver will fill out a data collection form then be instructed on how to use the NoseFrida. Next, family with trial it on their child while in the ED. Caregivers will then fill out a 7 point Likert survey on both the bulb suction and NoseFrida device. The family will go home with this device and a set of replacement filters and instructed to suction their child as needed. The primary investigator (PI) will then complete a 72 hour chart review to determine the number of return to ED visits and readmission rates. To compare ED returns with retrospective data, KSP will conduct a review of the business objects database using ICD9 codes specific for viral respiratory tract infections over the past 3 years to determine a control return ED visit rate. Data will be compared using a paired T-test. If data is not normally distributed we will use a Wilcoxon signed-rank test. We will also use a multivariable logistic model to examine associations adjusted for age and illness severity.

详细描述

Background The mainstay of treatment in viral upper and lower respiratory tract disease is airway clearance. Viral respiratory tract infections account for a substantial amount of emergency department (ED) visits, financial and stress burden on caregivers. In addition, they also account for a large number of ED return visits. While airway clearance is considered a mainstay of treatment the pragmatic effectiveness of various devices remain unstudied in patients who are discharged from the ED.

Hypothesis:

There is no difference between the NoseFrida and the bulb suction at relieving objective signs of nasal obstruction or return ED visits.

Study Objective:

  1. To compare the use of the NoseFrida device with a retrospective control (bulb suction) to determine if there is a decrease in the number of ED return visits.
  2. To provide evidence based recommendations on the pragmatic effectiveness of two commonly used suction devices.
  3. To provide a descriptive analysis on 72 hour return to ED rates and readmission rates.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 24 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Age 1 day-24 months presenting to the ED with a complaint of nasal congestion or symptoms of bronchiolitis who require suctioning.
  • •Parent/guardian has used a bulb suction device in the past.
  • •This is the first presentation to Vanderbilt Childrens Emergency Department for current illness.
  • •Patient will be discharged from the emergency room.
  • •Parent/Guardian is able to read English.

排除标准

  • •No upper airway abnormalities, i.e. cleft palate or choanal atresia.
  • •Previously enrolled in study.

研究组 & 干预措施

Bulb suction

Active Comparator

Patients in this arm will be given bulb suction to treat nasal congestion. This group will contain participants who have used bulb suction in the past.

干预措施: Bulb suction (Device)

NoseFrida

Experimental

Patients in this arm will be given the NoseFrida to treat nasal congestion. This group will contain participants who will trial the NoseFrida in the emergency department.

干预措施: NoseFrida (Device)

结局指标

主要结局

Parental satisfaction

时间窗: at baseline

Measured on a 7 point Likert scale from 1 to 7 with 7 being strongly agree

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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