Trial Outcomes & Findings for Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study (NCT NCT02219334)
NCT ID: NCT02219334
Last Updated: 2020-09-03
Results Overview
The study group will analyze the length of stay for the NoseFrida group and compare it with the NeoSucker group.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greater
Results posted on
2020-09-03
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
23
|
|
Overall Study
COMPLETED
|
24
|
20
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
7
|
3
|
Baseline Characteristics
Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study
Baseline characteristics by cohort
| Measure |
NoseFrida
n=24 Participants
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.
|
NeoSucker
n=20 Participants
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.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Length of stay
|
26.23 Hours
n=5 Participants
|
25.13 Hours
n=7 Participants
|
25.93 Hours
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greaterThe study group will analyze the length of stay for the NoseFrida group and compare it with the NeoSucker group.
Outcome measures
| Measure |
NoseFrida
n=24 Participants
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.
|
NeoSucker
n=20 Participants
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.
|
|---|---|---|
|
Comparison of Median Length of Stay of the Two Devices in Hours
|
26.23 Hours
Interval 17.63 to 40.48
|
25.13 Hours
Interval 19.7 to 45.42
|
OTHER_PRE_SPECIFIED outcome
Timeframe: within 48 hours of dischargeThe 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.
Outcome measures
| Measure |
NoseFrida
n=24 Participants
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.
|
NeoSucker
n=20 Participants
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.
|
|---|---|---|
|
Percentage of Patients Readmitted Within 48 Hours of Discharge.
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed for the duration of their stay in the EDOU, up to 48 Hours or end of hospitalization whichever is greaterPopulation: Parental satisfaction survey was only done on Nosefrida group since the Neosucker is the standard of care
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.
Outcome measures
| Measure |
NoseFrida
n=24 Participants
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.
|
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.
|
|---|---|---|
|
Parental Satisfaction (NoseFrida Group) Will be Measured Using a Newly Developed Survey Tool (Likert Scale).
|
5 score on a scale
Interval 1.0 to 5.0
|
—
|
Adverse Events
NoseFrida
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NeoSucker
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Shabana Yusuf/Associate Professor of Pediatrics
Baylor College of Medicine
Phone: 832-824-5388
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place