Clinical trial NCT03288857: Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis
Official title: Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Aspirator
Keywords: Naspira
Suctioning
Nasal suction device
Children
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Dell Children's Medical Center of Central Texas
First posted: 2017-09-20
Enrollment: 236
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to compare the standard bulb aspirator with that of a nasal oral aspirator. The hypothesis is that use of a nasal oral aspirator is more effective at removing nasal secretions in the treatment of bronchiolitis as measured by a predicted 50% decrease in the rate of unscheduled bronchiolitis return visits. The primary endpoint will be the number of unscheduled bronchiolitis return visits; secondary endpoints will include measurements of oral intake, respiratory relief, parental device preference and adverse events.

Detailed description: This study will be a single center, single blind, randomized controlled trial in the pediatric emergency department (ED) at Dell Children's Medical Center of Central Texas (DCMC). An ED discharge diagnosis of bronchiolitis will trigger patients to be randomized to receive a bulb aspirator or nasal oral aspirator for home secretion management use. Prior to dispensing the randomized aspirator, a pre-distribution questionnaire will be administered. Additionally, patients will receive a diary to complete for 3 days post ED discharge. Research personnel will call families on day 4 as a reminder to return the diary and again on day 14 to obtain a verbal post-study questionnaire. Research personnel will perform chart review on all patients looking for unscheduled patient return visits for bronchiolitis.

Eligibility criteria: Inclusion Criteria:

* Children \>28 days of life to \< 2 years of age discharged home from the DCMC ED with a diagnosis of bronchiolitis (diagnosis made per provider discretion)
* Caregiver fluent in English or Spanish

Exclusion Criteria:

* Previous enrollment
* Hospital admission
* Parental refusal to be randomized to an aspirator device (i.e., family prefers current device and does not wish to be randomized to a potentially different product)
* Current bacterial pneumonia
* Diagnosis of asthma
* Chronic lung disease
* Significant underlying cardiac disease
* Chronic neuromuscular disease

Primary outcomes:
measure: Unscheduled bronchiolitis return visits
timeFrame: 14 days
Secondary outcomes:
measure: Oral intake
timeFrame: 14 days
measure: Respiratory relief
timeFrame: 14 days
measure: Parental device preference
timeFrame: 14 days
measure: Adverse events
timeFrame: 14 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
Study officials:
References:
citation: Schwarz WW, Wilkinson M, Allen A. Randomized Controlled Trial Comparing the Bulb Aspirator With a Nasal-Oral Aspirator in the Treatment of Bronchiolitis. Pediatr Emerg Care. 2022 Feb 1;38(2):e529-e533. doi: 10.1097/PEC.0000000000002372.