Allergic Rhinitis, Nasal Congestion, Respiratory Tract Infection, Sinusitis
Conditions
Keywords
Nasal suction, Nasal aspiration, Nasal saline irrigation, Nasal lavage
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.
Interventions
DEVICEUse 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.
Sponsors
Aardvark Medical Company
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Ease of Use With the Device | 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 |
| Number of Participants Who Found the Device to be Effective | 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 |
| Number of Participants Who Identified the Device's User Manual as Easy to Understand | 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 |
| Number of Patients Who Were Observed to Have an Adverse Event | 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 |
| Number of Patients Experiencing a Physical Injury During Use | 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) |
Countries
United States
Participant flow
Recruitment details
The study was performed in a pediatric ambulatory clinic in July and August of 2009. The clinical coordinator identified patients as they presented to the clinic if they met inclusion criteria and informed consent was obtained before patient entry.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Parents of Congested Children |
|---|---|
| Age, Categorical <=18 years | 30 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 0.75 years STANDARD_DEVIATION 0.25 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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: 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
Time frame: Day one, immediately
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parents of Congested Children | Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device | 29 participants |
Comparison: Null hypothesis: Pr ≤ 0.7 versus HA: Pr \> 0.7; Pr is proportion using device appropriately. Observed rate calculated with exact 95% confidence interval from the binomial distribution. 2-sided p-value from binomial distribution.~With the proposed sample size of 30 subjects, we will reject the primary null hypothesis if at least 27 are observed to use the device properly. We will have 80% power for this to occur provided that the true rate in the population is at least 92%.p-value: 0.000595% CI: [0.83, 1]One-sample proportion
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
Time frame: Day one, immediately
Population: This was the total number of participants who answered this question.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parents of Congested Children | Number of Participants Who Experienced Ease of Use With the Device | 29 participants |
Comparison: Proportion responding \>=3 on a 5-point likert scale, with exact 95% confidence interval from the binomial distribution.95% CI: [0.83, 1]Descriptive
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
Time frame: Day one, immediately
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parents of Congested Children | Number of Participants Who Found the Device to be Effective | 29 participants |
Comparison: Descriptive summary of proportion responding \>=3 on 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.95% CI: [0.83, 1]Descriptive
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
Time frame: Day one, immediately
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parents of Congested Children | Number of Participants Who Identified the Device's User Manual as Easy to Understand | 30 participants |
Comparison: Descriptive summary of proportion responding \>=3 on a 5-point Likert scale, with exact 95% confidnce interval from the binomial distribution.95% CI: [0.88, 1]Descriptive
Secondary
Number of Patients Experiencing a Physical Injury During Use
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)
Time frame: Day one, immediately
Population: This is the total number of participants, all of whose children were examined after the procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parents of Congested Children | Number of Patients Experiencing a Physical Injury During Use | 0 paricipants |
Comparison: Descriptive summary of proportion found to have injury, with exact 95% confidnce interval from the binomial distribution.95% CI: [0, 0.12]Descriptive
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: 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
Time frame: Day one, immediately
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Parents of Congested Children | Number of Patients Who Were Observed to Have an Adverse Event | 0 patients with an adverse event |
Comparison: Descriptive summary of proportion observed to have a safety issue, with exact 95% confidnce interval from the binomial distribution.95% CI: [0, 0.12]Descriptive