Clinical trial NCT02219334: Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study
Official title: Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchiolitis
Keywords: Children
Nasal suction devices
Suctioning
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 55
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of our study is to determine the safety, efficacy, length of stay and parental satisfaction of the NoseFrida in comparison to a suction device used in the hospital setting in patients with bronchiolitis admitted under observation status.

Detailed 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 acute care setting is a common destination of patients with bronchiolitis. Patients are admitted to the acute care setting 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 acute care setting 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.

Eligibility criteria: 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)
* Patient admitted to the Pediatric Hospitalist Medicine (PHM) group
* Patient with associated hypoxemia and/or respiratory distress requiring low flow O2 nasal cannula (NC) management (2L/min or less)

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

Primary outcomes:
measure: Comparison of Median Length of Stay of the Two Devices in Hours
timeFrame: Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greater
Secondary outcomes:
Other outcomes:
measure: Percentage of Patients Readmitted Within 48 Hours of Discharge.
timeFrame: within 48 hours of discharge
measure: Parental Satisfaction (NoseFrida Group) Will be Measured Using a Newly Developed Survey Tool (Likert Scale).
timeFrame: Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greater
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Elizabeth L Watson, MSN, RN, CNL
role: STUDY_DIRECTOR
affiliation: Baylor College of Medicine
name: Aderonke Adekunle-Ojo, MD
role: STUDY_CHAIR
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