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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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ClinicalTrials.gov Identifier: NCT03666429
Recruitment Status : Not yet recruiting
First Posted : September 11, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
Fridababy
Information provided by (Responsible Party):
Sweeti Jain, Vanderbilt University Medical Center

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.


Condition or disease Intervention/treatment Phase
Upper Respiratory Tract Infections Nasal Suction Return Emergency Department Visits Device: Bulb suction Device: NoseFrida Not Applicable

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:

  1. 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.
  2. To provide evidence based recommendations on the pragmatic effectiveness of two commonly used suction devices.
  3. 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Arm Intervention/treatment
Active Comparator: Bulb suction
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.
Device: Bulb suction
Parents will use the bulb suction on their child in the emergency room then complete a 7 point likert survey.

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




Primary Outcome Measures :
  1. Parental satisfaction [ Time Frame: at baseline ]
    Measured on a 7 point Likert scale from 1 to 7 with 7 being strongly agree



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 1 day-24 months presenting to the ED with a complaint of nasal congestion or symptoms of bronchiolitis who require suctioning.
  2. Parent/guardian has used a bulb suction device in the past.
  3. This is the first presentation to Vanderbilt Childrens Emergency Department for current illness.
  4. Patient will be discharged from the emergency room.
  5. Parent/Guardian is able to read English.

Exclusion Criteria:

  1. No upper airway abnormalities, i.e. cleft palate or choanal atresia.
  2. Previously enrolled in study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666429


Contacts
Contact: Sweeti Jain, M.D. 931-212-0511 sweeti.b.jain@vumc.org
Contact: Donald Arnold, M.D. donald.arnold@vumc.org

Locations
United States, Tennessee
Vanderbilt Childrens Emergency Department Not yet recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Fridababy
Investigators
Study Chair: Donald Arnold, M.D. Vanderbilt University Medical Center

Responsible Party: Sweeti Jain, Clinical Fellow, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03666429     History of Changes
Other Study ID Numbers: 181365
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Emergencies
Respiratory Tract Infections
Nasal Obstruction
Disease Attributes
Pathologic Processes
Infection
Respiratory Tract Diseases
Nose Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases