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Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study

Primary Purpose

Bronchiolitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NoseFrida
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Children, Nasal suction devices, Suctioning

Eligibility Criteria

2 Months - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NoseFrida

NeoSucker

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2014
Last Updated
September 1, 2020
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02219334
Brief Title
Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study
Official Title
Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped due to low enrollment.
Study Start Date
September 2014 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Children, Nasal suction devices, Suctioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NoseFrida
Arm Type
Experimental
Arm Description
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.
Arm Title
NeoSucker
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NoseFrida
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of Median Length of Stay of the Two Devices in Hours
Description
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
Other Pre-specified Outcome Measures:
Title
Percentage of Patients Readmitted Within 48 Hours of Discharge.
Description
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
Title
Parental Satisfaction (NoseFrida Group) Will be Measured Using a Newly Developed Survey Tool (Likert Scale).
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth L Watson, MSN, RN, CNL
Organizational Affiliation
Baylor College of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aderonke Adekunle-Ojo, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
4684375
Citation
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Results Reference
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Citation
Budhiraja, S., Verma, R., Shields, M.D. (2012). The management of acute bronchiolitis in infants. Paidiatrics and Child Health, 23(7), 296-300.
Results Reference
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PubMed Identifier
17947838
Citation
Casati M, Picca M, Marinello R, Quartarone G. Safety of use, efficacy and degree of parental satisfaction with the nasal aspirator Narhinel in the treatment of nasal congestion in babies. Minerva Pediatr. 2007 Aug;59(4):315-25.
Results Reference
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PubMed Identifier
23809346
Citation
Da Dalt L, Bressan S, Martinolli F, Perilongo G, Baraldi E. Treatment of bronchiolitis: state of the art. Early Hum Dev. 2013 Jun;89 Suppl 1:S31-6. doi: 10.1016/S0378-3782(13)70011-2.
Results Reference
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PubMed Identifier
14670770
Citation
Deshpande SA, Northern V. The clinical and health economic burden of respiratory syncytial virus disease among children under 2 years of age in a defined geographical area. Arch Dis Child. 2003 Dec;88(12):1065-9. doi: 10.1136/adc.88.12.1065.
Results Reference
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Citation
Diagnosis and Managment of Bronchiolitis., 2006. Subcommittee on Diagnosis and Management of Bronchiolitis. 118, 1774.
Results Reference
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PubMed Identifier
19196675
Citation
Hall CB, Weinberg GA, Iwane MK, Blumkin AK, Edwards KM, Staat MA, Auinger P, Griffin MR, Poehling KA, Erdman D, Grijalva CG, Zhu Y, Szilagyi P. The burden of respiratory syncytial virus infection in young children. N Engl J Med. 2009 Feb 5;360(6):588-98. doi: 10.1056/NEJMoa0804877.
Results Reference
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PubMed Identifier
24333327
Citation
Jarvis K, Pirvu D, Barbee K, Berg N, Meyer M, Gaulke L, Pate BM, Roberts C. Change to a standardized airway clearance protocol for children with bronchiolitis leads to improved care. J Pediatr Nurs. 2014 May-Jun;29(3):252-7. doi: 10.1016/j.pedn.2013.11.007. Epub 2013 Nov 27.
Results Reference
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PubMed Identifier
14649194
Citation
Moore T. Suctioning techniques for the removal of respiratory secretions. Nurs Stand. 2003 Nov 12-18;18(9):47-53; quiz 54-5. doi: 10.7748/ns2003.11.18.9.47.c3504. Erratum In: Nurs Stand. 2003 Dec 10-16;18(13):31.
Results Reference
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PubMed Identifier
23460088
Citation
Mussman GM, Parker MW, Statile A, Sucharew H, Brady PW. Suctioning and length of stay in infants hospitalized with bronchiolitis. JAMA Pediatr. 2013 May;167(5):414-21. doi: 10.1001/jamapediatrics.2013.36.
Results Reference
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PubMed Identifier
22734014
Citation
Nagakumar P, Doull I. Current therapy for bronchiolitis. Arch Dis Child. 2012 Sep;97(9):827-30. doi: 10.1136/archdischild-2011-301579. Epub 2012 Jun 25.
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PubMed Identifier
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Citation
Sandweiss DR, Corneli HM, Kadish HA. Barriers to discharge from a 24-hour observation unit for children with bronchiolitis. Pediatr Emerg Care. 2010 Dec;26(12):892-6. doi: 10.1097/PEC.0b013e3181fe911d.
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Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study

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