Clinical trial NCT01129765: Home Usability of a Nasal Lavage System in Children
Official title: Home Usability of a Nasal Lavage System in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Congestion
Respiratory Tract Infection
Sinusitis
Allergic Rhinitis
Keywords: Nasal suction
Nasal aspiration
Nasal saline irrigation
Nasal lavage
Lead sponsor: Aardvark Medical Company
Sponsor class: INDUSTRY
First posted: 2010-05-25
Enrollment: 30
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants were selected from a primary care pediatric clinic.

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.

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.

Primary outcomes:
measure: Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device
timeFrame: Day one, immediately
Secondary outcomes:
measure: Number of Participants Who Experienced Ease of Use With the Device
timeFrame: Day one, immediately
measure: Number of Participants Who Found the Device to be Effective
timeFrame: Day one, immediately
measure: Number of Participants Who Identified the Device's User Manual as Easy to Understand
timeFrame: Day one, immediately
measure: Number of Patients Who Were Observed to Have an Adverse Event
timeFrame: Day one, immediately
measure: Number of Patients Experiencing a Physical Injury During Use
timeFrame: Day one, immediately
Other outcomes:
Locations:
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
Study officials:
affiliation: Advanced Pediatrics
name: Richard Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References: