Upper Respiratory Tract InfectionsNCT03666429
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
A study testing Bulb suction and NoseFrida in people with Upper Respiratory Tract Infections and Nasal Suction, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 24 months
- Conditions the study is for
- Upper Respiratory Tract Infections, Nasal Suction, Return Emergency Department Visits
- What is being tested?
- Bulb suction and NoseFrida
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- No upper airway abnormalities, i.e. cleft palate or choanal atresia.
- Previously enrolled in study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Childrens Emergency Department
Nashville, Tennessee, 37232
About this study
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.
Read the 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.
- Being tested
- Bulb suction, NoseFrida
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bulb suctionDevice
Parents will use the bulb suction on their child in the emergency room then complete a 7 point likert survey.
NoseFridaDevice
Parents will use the NoseFrida in the emergency department and complete a 7 point likert survey.
| Study group | Role | What they receive |
|---|---|---|
| Bulb suction | Active comparator | 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. Receives: Device: Bulb suction |
| NoseFrida | Experimental | 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. Receives: Device: NoseFrida |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental satisfaction
Measured on a 7 point Likert scale from 1 to 7 with 7 being strongly agree
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Jan 2020 (estimated)
- Primary completionNov 2020 (estimated)
- Study completionNov 2020 (estimated)
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fridababy
- Responsible party
- Sponsor
- Investigators
- Donald Arnold, M.D., Study chair, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666429
- Sponsor's protocol ID
- 181365
- Status last verified
- Dec 2020
- First submitted
- 9 Sep 2018
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03666429
- Acronym / sponsor ID
- 181365
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Fridababy
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bulb suction | Active comparator | Device: Bulb suctionPatients 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. |
| NoseFrida | Experimental | Device: NoseFridaPatients 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. |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- No upper airway abnormalities, i.e. cleft palate or choanal atresia.
- Previously enrolled in study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bulb suctionParents will use the bulb suction on their child in the emergency room then complete a 7 point likert survey. | Device | Bulb suction |
| NoseFridaParents will use the NoseFrida in the emergency department and complete a 7 point likert survey. | Device | NoseFrida |
Primary outcome
Parental satisfaction
Time frame: at baseline
Measured on a 7 point Likert scale from 1 to 7 with 7 being strongly agree
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Upper Respiratory Tract Infections
RecruitingObservational study
A Multi-modal Cohort Study of Brown Adipose Tissue Based on Paired Comparisons at Room Temperature and After Cold Exposure
Brown Adipose Tissue, Human
Active, not recruitingPhase 2
OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC
Platinum-sensitive Ovarian Cancer, Relapsed Ovarian Cancer
Recruiting
Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
Acute Respiratory Illness, Viral Respiratory Infection
Recruiting
Probiotic Trial for URTI Prevention in Healthy Adults
Upper Respiratory Tract Infections
RecruitingPhase 3
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Chronic Inducible Urticaria, Cold Urticaria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Arnold, M.D. study chair
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bulb suction and NoseFrida in people with Upper Respiratory Tract Infections and Nasal Suction, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental satisfaction (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.