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

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.

Conditions

• Upper Respiratory Tract Infections
• Nasal Suction
• Return Emergency Department Visits

Interventions

DEVICE

Bulb suction

Parents will use the bulb suction on their child in the emergency room then complete a 7 point likert survey.

DEVICE

NoseFrida

Parents will use the NoseFrida in the emergency department and complete a 7 point likert survey.

Sponsors & Collaborators

• Fridababy

  collaborator INDUSTRY

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Donald Arnold, M.D. · Vanderbilt University Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Day

Max Age

24 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-01

Primary Completion

2020-11-30

Completion

2020-11-30

FDA Device

Yes

Countries

• United States

Study Locations