N/A
N=30
Home Usability of a Nasal Lavage System in Children
Nasal Congestion · Respiratory Tract Infection · Sinusitis · Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01129765 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcome: Primary: Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device — 29 participants — p=0.0005
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Use of an automatic nasal irrigator/aspirator (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Aardvark Medical Company
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device |
29 | 0.0005 sig |
| SECONDARY Number of Participants Who Experienced Ease of Use With the Device |
29 | — |
| SECONDARY Number of Participants Who Found the Device to be Effective |
29 | — |
| SECONDARY Number of Participants Who Identified the Device's User Manual as Easy to Understand |
30 | — |
| SECONDARY Number of Patients Who Were Observed to Have an Adverse Event |
— | — |
| SECONDARY Number of Patients Experiencing a Physical Injury During Use |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01129765). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.