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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
236
NeilMed Naspira is a nasal-oral aspirator
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
Unscheduled bronchiolitis return visits
The number of unscheduled bronchiolitis return visits (return to either ED, urgent care or PCP)
Time frame: 14 days
Oral intake
Effects of device on oral intake as determined by diary and post-study questionnaire
Time frame: 14 days
Respiratory relief
Effects of device on respiratory relief as determined by diary and post-study questionnaire
Time frame: 14 days
Parental device preference
Parental device preference as determined by diary and post-study questionnaire
Time frame: 14 days
Adverse events
Description of adverse events as determined by diary and post-study questionnaire
Time frame: 14 days
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