Home Usability of a Nasal Lavage System in Children

NCT ID: NCT01129765

Last Updated: 2010-08-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2009-08-31

Brief Summary

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.

Detailed Description

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.

The primary outcome was proper use of device that was precisely defined. Additionally, subjective efficacy of mucus removal, evidence of adverse events and understanding of the device's user manual were also measured.

Conditions

Nasal Congestion; Respiratory Tract Infection; Sinusitis; Allergic Rhinitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Parents of congested children

Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.

Use of an automatic nasal irrigator/aspirator

Intervention Type: DEVICE

After reading the device's user manual, parents were asked to use it on their congested children to their satisfaction. During this time, a clinical observer recorded predetermined steps that needed to be performed for success as well as presence of any adverse events.

Interventions

Use of an automatic nasal irrigator/aspirator

After reading the device's user manual, parents were asked to use it on their congested children to their satisfaction. During this time, a clinical observer recorded predetermined steps that needed to be performed for success as well as presence of any adverse events.

Intervention Type: DEVICE

Other Intervention Names

Nasal aspiration; Nasal irrigation; Nasal lavage

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aardvark Medical Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Advanced Pediatrics

Principal Investigators

Richard Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Pediatrics

Locations

Advanced Pediatrics

Vienna, Virginia, United States

Countries

United States

Other Identifiers

AM-002

Identifier Type: -

Identifier Source: org_study_id