This trial is active, not recruiting.

Condition bronchiolitis
Treatment nosefrida
Sponsor Baylor College of Medicine
Collaborator Texas Children's Hospital
Start date September 2014
End date May 2016
Trial size 150 participants
Trial identifier NCT02219334, H-33659


The purpose of our study is to determine the safety, efficacy, length of stay and parental satisfaction of the NoseFrida in comparison to suction devices used in the hospital setting in patients with bronchiolitis in the Emergency Department Observation Unit (EDOU).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.
The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning.
(No Intervention)
The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients.

Primary Outcomes

Percentage of (NoseFrida) patients discharged home before the current mean length of stay of 25.7 hours.
time frame: Participants will be followed for the duration of their stay in the EDOU, an expected mean length of stay of 25.7 hours.

Secondary Outcomes

Number of participants with serious and non-serious adverse events
time frame: Participants will be followed for the duration of their stay in the EDOU, an expected mean length of stay of 25.7 hours.

Eligibility Criteria

Male or female participants from 2 months up to 2 years old.

Inclusion Criteria: - patients above the age of 2 months and post-gestational age to 44 weeks and less than or equal to 2 years with signs and symptoms of bronchiolitis - clinical respiratory score (CRS) of less than or equal to 4 - principle diagnosis of bronchiolitis (International Classification of Diseases-9: 466, 466.11 and 466.19) Exclusion Criteria: - age less than 2 months - age less than post-gestational age 44 weeks - CRS greater than 4 - associated hypoxia - already using NoseFrida at home - chronic lung disease - oro-facial abnormalities - cardiac abnormalities

Additional Information

Official title Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study
Principal investigator Elizabeth L Watson, BSN
Description Bronchiolitis is a viral illness and a common cause for admission to the hospital. Most patients with bronchiolitis are managed at home. The indications of hospitalization are poor feeding (due to increased mucus production) and respiratory distress with and without hypoxia. The EDOU is a common destination of patients with bronchiolitis. Patients are admitted to the EDOU for respiratory monitoring, suctioning and poor oral intake. The management of bronchiolitis is mostly supportive which includes frequent feedings, nasal suctioning, intravenous fluids and oxygen if necessary. The patients admitted to the EDOU receive frequent nasal suctioning by a suction device (NeoSucker) and deep suctioning as needed. Since young infants are "nose breathers," the use of nasal suctioning helps to relieve nasal congestion/upper airway obstruction and assists with their ability to breathe and feed. Suctioning can be accomplished by the use of the bulb suction, nasal aspirators and/or suction catheters connected to pressure devices. The role of the type of suctioning device in the management of bronchiolitis has not been studied extensively. In our study, a nasal aspirator (developed in Sweden by an Ear, Nose and Throat specialist) by the brand name of NoseFrida will be compared to the NeoSucker, a suction catheter currently used in our hospital setting which requires both a nurse and a pressure device. Nasal suctioning is less traumatic and does not cause the discomfort, bleeding and rebound swelling that deep suctioning can. Upon admission, patients will be randomized to either the NoseFrida or NeoSucker group. After consent is obtained for agreed participation, the patients parents randomized to the NoseFrida group will be given a NoseFrida/filters and instructions on usage (instructional video/postcard). The parents will be encouraged to use the NoseFrida suction device as often as they want, especially before feeds and sleep. The patients randomized to the NeoSucker group will be given the current standard of care and nasal suctioned by a nurse. Both groups will be deep suctioned as clinically needed.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.