Aspirator, Bronchiolitis
Conditions
Keywords
Naspira, Suctioning, Nasal suction device, Children
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.
Interventions
DEVICENeilMed Naspira
NeilMed Naspira is a nasal-oral aspirator
Sponsors
Dell Children's Medical Center of Central Texas
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Months to 24 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unscheduled bronchiolitis return visits | 14 days | The number of unscheduled bronchiolitis return visits (return to either ED, urgent care or PCP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral intake | 14 days | Effects of device on oral intake as determined by diary and post-study questionnaire |
| Respiratory relief | 14 days | Effects of device on respiratory relief as determined by diary and post-study questionnaire |
| Parental device preference | 14 days | Parental device preference as determined by diary and post-study questionnaire |
| Adverse events | 14 days | Description of adverse events as determined by diary and post-study questionnaire |
Countries
United States
Outcome results
None listed