Home Usability of a Nasal Lavage System in Children

Allergic Rhinitis Clinical Trial

Official title:

Home Usability of a Nasal Lavage System in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129765
• Other study ID #: AM-002
• Status: Completed
• Phase: N/A
• First received: May 21, 2010
• Last updated: July 27, 2010
• Start date: July 2009
• Est. completion date: August 2009

Study information

• Verified date: July 2010
• Source: Aardvark Medical Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Allergic Rhinitis
• Nasal Congestion
• Respiratory Tract Infection
• Respiratory Tract Infections
• Sinusitis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Advanced Pediatrics	Vienna	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Aardvark Medical Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device	'Proper use' is defined as successfully completing all of the following five steps: Attaching wash-head to handle properly; Positioning child correctly for procedure as per the user manual's instructions; Using the device's control button correctly for both irrigation and aspiration; Placing the wash-head tip correctly at the nasal opening; Using the device for up to but not exceeding five seconds	Day one, immediately	Yes
Secondary	Number of Participants Who Experienced Ease of Use With the Device	After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. An answer of 3 or greater is considered an affirmative answer. Such responses reported along with the exact 95% confidence intervals.; The question and scale are as follows: How easy was the device to use?; 1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy	Day one, immediately	Yes
Secondary	Number of Participants Who Found the Device to be Effective	After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. The proportion answering 3 or greater is reported along with the exact 95% confidence intervals.; The question and scale are as follows: How well did the device remove nasal secretions?; 1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy	Day one, immediately	No
Secondary	Number of Participants Who Identified the Device's User Manual as Easy to Understand	After using the device, the caregiver answered this question on a five point Likert-like scale with increasing favorability with increasing number. The proportion answering 3 or greater is reported along with the exact 95% confidence intervals.; The question and scale are as follows: How easy was the manual to understand?; 1 difficult, 2 somewhat hard, 3 fairly easy, 4 easy, 5 very easy	Day one, immediately	Yes
Secondary	Number of Patients Who Were Observed to Have an Adverse Event	While using the device, the patients were observed by the research coordinator for any of the following adverse events to occur: bloody nose; being sprayed in the eye with the saline; vomiting after the procedure; choking during or after the procedure; other	Day one, immediately	Yes
Secondary	Number of Patients Experiencing a Physical Injury During Use	After the procedure, the patient was directly examined for any of the following: bleeding from the nostrils; disruption of the skin around the nose; increased work of breathing/respiratory distress (increased respiratory rate, increased respiratory accessory muscle use)	Day one, immediately	Yes