跳至主要内容
临床试验/NCT01129765
NCT01129765已完成不适用

Home Usability of a Nasal Lavage System in Children

Aardvark Medical Company1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device

研究概览

简要总结

This study evaluates labeling comprehension, ease of use and effectiveness of a new device for nasal and sinus irrigation and/or aspiration. The device is currently cleared for professional use and home use with a prescription. This is a usability study to demonstrate that this device is appropriate for home use.

详细描述

Nasal congestion is an important complication of viral upper respiratory infections in young children. It can lead to poor eating, sleeping and breathing. Recently, the FDA recommended against using over-the-counter cold remedies in young children because of inefficacy and occasional dangerous side effects. A commonly recommended non-drug solution for nasal congestion is nasal suctioning. This can be effective but currently available methods have been found to be awkward, uncomfortable and ineffective.

The studied device has potential for making nasal suctioning easy to perform in the home setting, especially in young children. It is already FDA cleared for professional use and this study was developed to demonstrate that it is appropriate for the home as well. This would be significant as it would allow parents a strategy of clearing their child's nose without drugs.

The device is automatic and handheld that can irrigate and/or aspirate the nasal cavity with hospital-grade suction. The handle houses a pump that can achieve air flows known to be effective for infant nasal suctioning in the hospital. A disposable wash-head is placed on top. It has an irrigation chamber with 0.9% saline and another chamber for collecting the aspirated nasal contents. The unit operates from a single bi-functional button.

Several key safety features have been built in such as: a tip that is shaped to maximize the seal but prevent intrusion into the nose; an irrigation function that delivers an optimal volume but prevents flooding the nasal cavity; and a pump that can deliver suction known to be effective in the hospital but whose safety valve does not allow it to rise above dangerous levels.

Participants were parents of children who have nasal congestion for whom nasal suctioning is traditionally recommended. They were asked to review the instruction manual of the device, and then use it on their children.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parents of children less than 6 years of age who were suffering from nasal congestion for which nasal suctioning and salt water irrigation/drops are prescribed.

排除标准

  • Parents of children in marked respiratory distress or who maxillofacial malformations not conducive to nasal suctioning.
  • Additionally, parents of children with recurrent nose bleeds, bleeding disorders or irritated peri-nasal skin were excluded.

结局指标

主要结局

Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device

时间窗: Day one, immediately

'Proper use' is defined as successfully completing all of the following five steps: 1. Attaching wash-head to handle properly 2. Positioning child correctly for procedure as per the user manual's instructions 3. Using the device's control button correctly for both irrigation and aspiration 4. Placing the wash-head tip correctly at the nasal opening 5. Using the device for up to but not exceeding five seconds

次要结局

  • Number of Participants Who Experienced Ease of Use With the Device(Day one, immediately)
  • Number of Participants Who Found the Device to be Effective(Day one, immediately)
  • Number of Participants Who Identified the Device's User Manual as Easy to Understand(Day one, immediately)
  • Number of Patients Who Were Observed to Have an Adverse Event(Day one, immediately)
  • Number of Patients Experiencing a Physical Injury During Use(Day one, immediately)

研究者

发起方
Aardvark Medical Company
申办方类型
Industry

研究点 (1)

Loading locations...

相似试验