Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis
| Status: | Recruiting |
|---|---|
| Conditions: | Bronchitis |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/1/2017 |
| Start Date: | November 22, 2017 |
| End Date: | June 2019 |
| Contact: | Whitney W Schwarz, MD |
| Email: | wwroe87@gmail.com |
| Phone: | 5126324596 |
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.
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.
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.
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
We found this trial at
1
site
4900 Mueller Boulevard
Austin, Texas 78723
Austin, Texas 78723
(512) 324-0000
Phone: 512-632-4596
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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