Trial Outcomes & Findings for Home Usability of a Nasal Lavage System in Children (NCT NCT01129765)
NCT ID: NCT01129765
Last Updated: 2010-08-03
Results Overview
'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
COMPLETED
30 participants
Day one, immediately
2010-08-03
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home Usability of a Nasal Lavage System in Children
Baseline characteristics by cohort
| Measure |
Parents of Congested Children
n=30 Participants
Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
|
|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
0.75 years
STANDARD_DEVIATION 0.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Parents of Congested Children
n=30 Participants
Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
|
|---|---|
|
Number of Participants Who Properly Used the Nasal Irrigator/Aspirator Device
|
29 participants
|
SECONDARY outcome
Timeframe: Day one, immediatelyPopulation: This was the total number of participants who answered this question.
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
Outcome measures
| Measure |
Parents of Congested Children
n=30 Participants
Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
|
|---|---|
|
Number of Participants Who Experienced Ease of Use With the Device
|
29 participants
|
SECONDARY outcome
Timeframe: Day one, immediatelyAfter 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
Outcome measures
| Measure |
Parents of Congested Children
n=30 Participants
Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
|
|---|---|
|
Number of Participants Who Found the Device to be Effective
|
29 participants
|
SECONDARY outcome
Timeframe: Day one, immediatelyAfter 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
Outcome measures
| Measure |
Parents of Congested Children
n=30 Participants
Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
|
|---|---|
|
Number of Participants Who Identified the Device's User Manual as Easy to Understand
|
30 participants
|
SECONDARY outcome
Timeframe: Day one, immediatelyWhile 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
Outcome measures
| Measure |
Parents of Congested Children
n=30 Participants
Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
|
|---|---|
|
Number of Patients Who Were Observed to Have an Adverse Event
|
0 patients with an adverse event
|
SECONDARY outcome
Timeframe: Day one, immediatelyPopulation: This is the total number of participants, all of whose children were examined after the procedure.
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)
Outcome measures
| Measure |
Parents of Congested Children
n=30 Participants
Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
|
|---|---|
|
Number of Patients Experiencing a Physical Injury During Use
|
0 paricipants
|
Adverse Events
Parents of Congested Children
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place