Bronchiolitis
Conditions
Keywords
Children, Nasal suction devices, Suctioning
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.
Interventions
DEVICENoseFrida
The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Median Length of Stay of the Two Devices in Hours | Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greater | The study group will analyze the length of stay for the NoseFrida group and compare it with the NeoSucker group. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Readmitted Within 48 Hours of Discharge. | within 48 hours of discharge | The study group will analyze those patients both from the NoseFrida group and the NeoSucker group who are readmitted within 48 hours of discharge from the EDOU. |
| Parental Satisfaction (NoseFrida Group) Will be Measured Using a Newly Developed Survey Tool (Likert Scale). | Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greater | A study specific survey was developed to measure parental satisfaction of the NoseFrida device. The parental satisfaction question responses were on a 5 point Likert Scale as follows: 1=Strongly Disagree, 2=Disagree, 3=Neutral, 4=Agree and 5=Strongly Agree. The minimum value is strongly disagree and maximum is strongly agree. The likert scale assessed parental satisfaction with the use of the device. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NoseFrida If randomized to the NoseFrida group, the NoseFrida/filters will be given along with educational instruction of its use to the parents of patients admitted with bronchiolitis. The NoseFrida will be used by the parent to suction the nares of their infants/toddlers.
NoseFrida: The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning. | 24 |
| NeoSucker The NeoSucker (used for nasal suctioning) is part of the current standard of care for patients with bronchiolitis. The NeoSucker is used for removing nasal secretions by a nurse or respiratory therapist. The NeoSucker is a plastic tube which is used to suction the secretions. The bedside nurse will continue to use the NeoSucker as needed. NoseFrida will not be used for this sub group of patients. | 20 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 7 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | NoseFrida | Total | NeoSucker |
|---|---|---|---|
| Age, Categorical <=18 years | 24 Participants | 44 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 17 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 27 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Length of stay | 26.23 Hours | 25.93 Hours | 25.13 Hours |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 17 Participants | 32 Participants | 15 Participants |
| Sex: Female, Male Female | 11 Participants | 18 Participants | 7 Participants |
| Sex: Female, Male Male | 13 Participants | 26 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 23 |
| other Total, other adverse events | 0 / 32 | 0 / 23 |
| serious Total, serious adverse events | 0 / 32 | 0 / 23 |
Outcome results
Primary
Comparison of Median Length of Stay of the Two Devices in Hours
The study group will analyze the length of stay for the NoseFrida group and compare it with the NeoSucker group.
Time frame: Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greater
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NoseFrida | Comparison of Median Length of Stay of the Two Devices in Hours | 26.23 Hours |
| NeoSucker | Comparison of Median Length of Stay of the Two Devices in Hours | 25.13 Hours |
Comparison: The primary hypothesis of length of stay equivalence within a margin of ± 5 hours was tested using the two one-sided t-test (TOST) procedure, with a 5% significance level.p-value: <0.0595% CI: [-10.74, 15.72]two one-sided t-test (TOST)
Other Pre-specified
Parental Satisfaction (NoseFrida Group) Will be Measured Using a Newly Developed Survey Tool (Likert Scale).
A study specific survey was developed to measure parental satisfaction of the NoseFrida device. The parental satisfaction question responses were on a 5 point Likert Scale as follows: 1=Strongly Disagree, 2=Disagree, 3=Neutral, 4=Agree and 5=Strongly Agree. The minimum value is strongly disagree and maximum is strongly agree. The likert scale assessed parental satisfaction with the use of the device.
Time frame: Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greater
Population: Parental satisfaction survey was only done on Nosefrida group since the Neosucker is the standard of care
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| NoseFrida | Parental Satisfaction (NoseFrida Group) Will be Measured Using a Newly Developed Survey Tool (Likert Scale). | 5 score on a scale |
Other Pre-specified
Percentage of Patients Readmitted Within 48 Hours of Discharge.
The study group will analyze those patients both from the NoseFrida group and the NeoSucker group who are readmitted within 48 hours of discharge from the EDOU.
Time frame: within 48 hours of discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NoseFrida | Percentage of Patients Readmitted Within 48 Hours of Discharge. | 1 Participants |
| NeoSucker | Percentage of Patients Readmitted Within 48 Hours of Discharge. | 0 Participants |