Effectiveness of the NoseFrida Compared With Bulb Suction at Relieving Objective Signs of Nasal Obstruction and Reducing Return Visits in Pediatric Patients Presenting to the Emergency Department
Primary Purpose
Upper Respiratory Tract Infections, Nasal Suction, Return Emergency Department Visits
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bulb suction
NoseFrida
Sponsored by
About this trial
This is an interventional treatment trial for Upper Respiratory Tract Infections
Eligibility Criteria
Inclusion Criteria:
- Age 1 day-24 months presenting to the ED with a complaint of nasal congestion or symptoms of bronchiolitis who require suctioning.
- Parent/guardian has used a bulb suction device in the past.
- This is the first presentation to Vanderbilt Childrens Emergency Department for current illness.
- Patient will be discharged from the emergency room.
- Parent/Guardian is able to read English.
Exclusion Criteria:
- No upper airway abnormalities, i.e. cleft palate or choanal atresia.
- Previously enrolled in study.
Sites / Locations
- Vanderbilt Childrens Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Bulb suction
NoseFrida
Arm Description
Patients in this arm will be given bulb suction to treat nasal congestion. This group will contain participants who have used bulb suction in the past.
Patients in this arm will be given the NoseFrida to treat nasal congestion. This group will contain participants who will trial the NoseFrida in the emergency department.
Outcomes
Primary Outcome Measures
Parental satisfaction
Measured on a 7 point Likert scale from 1 to 7 with 7 being strongly agree
Secondary Outcome Measures
Full Information
NCT ID
NCT03666429
First Posted
September 9, 2018
Last Updated
December 1, 2020
Sponsor
Vanderbilt University Medical Center
Collaborators
Fridababy
1. Study Identification
Unique Protocol Identification Number
NCT03666429
Brief Title
Effectiveness of the NoseFrida Compared With Bulb Suction at Relieving Objective Signs of Nasal Obstruction and Reducing Return Visits in Pediatric Patients Presenting to the Emergency Department
Official Title
Effectiveness of the NoseFrida Compared With Bulb Suction at Relieving Objective Signs of Nasal Obstruction and Reducing Return Visits in Pediatric Patients Presenting to the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institution
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
Fridababy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The mainstay of treatment in viral upper and lower respiratory tract disease is airway clearance. Viral respiratory tract infections account for a substantial amount of emergency department (ED) visits, financial and stress burden on caregivers. In addition, they also account for a large number of ED return visits. While airway clearance is considered a mainstay of treatment the pragmatic effectiveness of various devices remain unstudied in patients who are discharged from the ED.
The objectives of this study are to compare the pragmatic effectiveness of two commonly used suction devices the NoseFrida and bulb suction and to provide a descriptive analysis on 72 hour return to ED rates and readmission rates. Patients will be enrolled October 15, 2018 to October 15, 2019 or until NoseFrida supplies are depleted. Fridababy will supply 500 NoseFrida devices and replacement filters. Patients aged 1 day to 24 months presenting Vanderbilt Childrens ED with symptoms of nasal congestion or bronchiolitis who require suctioning and will be discharged from the ED will be approached for enrollment. Exclusion criteria include no upper airway abnormalities or previously enrolled in study. The study design is a prospective and retrospective observational study. We anticipate about 500 patients to be enrolled in this study. Families will then be approached for consent to participate. Caregiver will fill out a data collection form then be instructed on how to use the NoseFrida. Next, family with trial it on their child while in the ED. Caregivers will then fill out a 7 point Likert survey on both the bulb suction and NoseFrida device. The family will go home with this device and a set of replacement filters and instructed to suction their child as needed. The primary investigator (PI) will then complete a 72 hour chart review to determine the number of return to ED visits and readmission rates. To compare ED returns with retrospective data, KSP will conduct a review of the business objects database using ICD9 codes specific for viral respiratory tract infections over the past 3 years to determine a control return ED visit rate. Data will be compared using a paired T-test. If data is not normally distributed we will use a Wilcoxon signed-rank test. We will also use a multivariable logistic model to examine associations adjusted for age and illness severity.
Detailed Description
Background The mainstay of treatment in viral upper and lower respiratory tract disease is airway clearance. Viral respiratory tract infections account for a substantial amount of emergency department (ED) visits, financial and stress burden on caregivers. In addition, they also account for a large number of ED return visits. While airway clearance is considered a mainstay of treatment the pragmatic effectiveness of various devices remain unstudied in patients who are discharged from the ED.
Hypothesis:
There is no difference between the NoseFrida and the bulb suction at relieving objective signs of nasal obstruction or return ED visits.
Study Objective:
To compare the use of the NoseFrida device with a retrospective control (bulb suction) to determine if there is a decrease in the number of ED return visits.
To provide evidence based recommendations on the pragmatic effectiveness of two commonly used suction devices.
To provide a descriptive analysis on 72 hour return to ED rates and readmission rates.
Methods:
The study design is a prospective and retrospective observational study. We anticipate about 500 patients to be enrolled in this study. Patients who present to Vanderbilt Childrens Emergency Department will be identified by key study personnel (KSP) based on inclusion and exclusion criteria. Families will then be approached for consent to participate. Caregiver will fill out a data collection form then be instructed on how to use the NoseFrida. Next, family with trial it on their child while in the ED. Caregivers will then fill out a 7 point Likert survey on both the bulb suction and NoseFrida device. The family will go home with this device and a set of replacement filters and instructed to suction their child as needed. The primary investigator (PI) will then complete a 72 hour chart review to determine the number of return to ED visits and readmission rates. The family will keep the suction device at the completion of the study. To compare ED returns with retrospective data, KSP will conduct a review of the business objects database using ICD9 codes specific for viral respiratory tract infections over the past 3 years to determine a control return ED visit rate. Data will be compared using a paired T-test. If data is not normally distributed we will use a Wilcoxon signed-rank test. We will also use a multivariable logistic model to examine associations adjusted for age and illness severity. Fridababy will provide supplies needed for the study, however the company will not have access to the raw data or PHI. Once the results are published in a scientific journal, then Fridababy will have access to the results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections, Nasal Suction, Return Emergency Department Visits
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bulb suction
Arm Type
Active Comparator
Arm Description
Patients in this arm will be given bulb suction to treat nasal congestion. This group will contain participants who have used bulb suction in the past.
Arm Title
NoseFrida
Arm Type
Experimental
Arm Description
Patients in this arm will be given the NoseFrida to treat nasal congestion. This group will contain participants who will trial the NoseFrida in the emergency department.
Intervention Type
Device
Intervention Name(s)
Bulb suction
Intervention Description
Parents will use the bulb suction on their child in the emergency room then complete a 7 point likert survey.
Intervention Type
Device
Intervention Name(s)
NoseFrida
Intervention Description
Parents will use the NoseFrida in the emergency department and complete a 7 point likert survey.
Primary Outcome Measure Information:
Title
Parental satisfaction
Description
Measured on a 7 point Likert scale from 1 to 7 with 7 being strongly agree
Time Frame
at baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 1 day-24 months presenting to the ED with a complaint of nasal congestion or symptoms of bronchiolitis who require suctioning.
Parent/guardian has used a bulb suction device in the past.
This is the first presentation to Vanderbilt Childrens Emergency Department for current illness.
Patient will be discharged from the emergency room.
Parent/Guardian is able to read English.
Exclusion Criteria:
No upper airway abnormalities, i.e. cleft palate or choanal atresia.
Previously enrolled in study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Arnold, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vanderbilt Childrens Emergency Department
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of the NoseFrida Compared With Bulb Suction at Relieving Objective Signs of Nasal Obstruction and Reducing Return Visits in Pediatric Patients Presenting to the Emergency Department
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