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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of an automatic nasal irrigator/aspirator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device | 'Proper use' is defined as successfully completing all of the following five steps:
| Day one, immediately |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The participants were selected from a primary care pediatric clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Schwartz, MD | Advanced Pediatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Pediatrics | Vienna | Virginia | 22180 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | This was the total number of participants who answered this question. | Posted | Number | participants | Day one, immediately |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Margaret Thorne | Advanced Pediatrics | 703-938-5555 | mthorne@pop.powweb.com |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| D012141 | Respiratory Tract Infections |
| D012852 | Sinusitis |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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| ID | Term |
|---|---|
| D055556 | Nasal Lavage |
| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
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| Day one, immediately |
| 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 |
| 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 |
| 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:
| Day one, immediately |
| Number of Patients Experiencing a Physical Injury During Use | After the procedure, the patient was directly examined for any of the following:
| Day one, immediately |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
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|
|
| 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 | Posted | Number | participants | Day one, immediately |
|
|
|
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| 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:
| Posted | Number | participants | Day one, immediately |
|
|
|
|
| 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 | Posted | Number | participants | Day one, immediately |
|
|
|
|
| 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:
| Posted | Number | patients with an adverse event | Day one, immediately |
|
|
|
|
| Secondary | Number of Patients Experiencing a Physical Injury During Use | After the procedure, the patient was directly examined for any of the following:
| This is the total number of participants, all of whose children were examined after the procedure. | Posted | Number | paricipants | Day one, immediately |
|
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| 0 |
| 30 |
| 0 |
| 30 |
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| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D012220 | Rhinitis |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |