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Home Usability of a Nasal Lavage System in Children

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ClinicalTrials.gov Identifier: NCT01129765
Recruitment Status : Completed
First Posted : May 25, 2010
Results First Posted : July 5, 2010
Last Update Posted : August 3, 2010
Sponsor:
Information provided by:
Aardvark Medical Company

Study Description
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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.

Condition or disease Intervention/treatment
Nasal Congestion Respiratory Tract Infection Sinusitis Allergic Rhinitis Device: Use of an automatic nasal irrigator/aspirator

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.


Study Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Home Usability of a Nasal Lavage System in Children
Study Start Date : July 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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.
Other Names:
  • Nasal aspiration
  • Nasal irrigation
  • Nasal lavage


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device [ Time Frame: 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


Secondary Outcome Measures :
  1. Number of Participants Who Experienced Ease of Use With the Device [ Time Frame: Day one, immediately ]

    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


  2. Number of Participants Who Found the Device to be Effective [ Time Frame: Day one, immediately ]

    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


  3. Number of Participants Who Identified the Device's User Manual as Easy to Understand [ Time Frame: Day one, immediately ]

    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


  4. Number of Patients Who Were Observed to Have an Adverse Event [ Time Frame: Day one, immediately ]

    While using the device, the patients were observed by the research coordinator for any of the following adverse events to occur:

    1. bloody nose
    2. being sprayed in the eye with the saline
    3. vomiting after the procedure
    4. choking during or after the procedure
    5. other

  5. Number of Patients Experiencing a Physical Injury During Use [ Time Frame: Day one, immediately ]

    After the procedure, the patient was directly examined for any of the following:

    1. bleeding from the nostrils
    2. disruption of the skin around the nose
    3. increased work of breathing/respiratory distress (increased respiratory rate, increased respiratory accessory muscle use)


Eligibility Criteria
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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The participants were selected from a primary care pediatric clinic.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129765


Locations
United States, Virginia
Advanced Pediatrics
Vienna, Virginia, United States, 22180
Sponsors and Collaborators
Aardvark Medical Company
Investigators
Principal Investigator: Richard Schwartz, MD Advanced Pediatrics
More Information
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Responsible Party: Richard Schwartz, MD, Advanced Pediatrics
ClinicalTrials.gov Identifier: NCT01129765     History of Changes
Other Study ID Numbers: AM-002
First Posted: May 25, 2010    Key Record Dates
Results First Posted: July 5, 2010
Last Update Posted: August 3, 2010
Last Verified: July 2010

Keywords provided by Aardvark Medical Company:
Nasal suction
Nasal aspiration
Nasal saline irrigation
Nasal lavage

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Sinusitis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Infection
Paranasal Sinus Diseases