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

• ClinicalTrials.gov Identifier: NCT02219334
• Recruitment Status: Terminated
• First Posted: August 18, 2014
• Results First Posted: September 3, 2020
• Last Update Posted: September 3, 2020
• Sponsor: Baylor College of Medicine
• Information provided by (Responsible Party): Shabana Yusuf, Baylor College of Medicine

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.

Condition or disease	Intervention/treatment	Phase
Bronchiolitis	Device: NoseFrida	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study
• Actual Study Start Date: September 2014
• Actual Primary Completion Date: May 2019
• Actual Study Completion Date: May 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: 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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. Comparison of Median Length of Stay of the Two Devices in Hours [ 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 ]
   The study group will analyze the length of stay for the NoseFrida group and compare it with the NeoSucker group.

Other Outcome Measures:

1. Percentage of Patients Readmitted Within 48 Hours of Discharge. [ Time Frame: 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.
2. Parental Satisfaction (NoseFrida Group) Will be Measured Using a Newly Developed Survey Tool (Likert Scale). [ 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 2 Months to 2 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Texas

Texas Children's Hospital

Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

• Study Director: Elizabeth L Watson, MSN, RN, CNL; Baylor College of Medicine
• Study Chair: Aderonke Adekunle-Ojo, MD; Baylor College of Medicine

  Study Documents (Full-Text)

Documents provided by Shabana Yusuf, Baylor College of Medicine:

Study Protocol and Statistical Analysis Plan  [PDF] October 11, 2019

More Information

Publications:

Benincaso FV, Smith MH. A suction-controlled nasal aspirator for collection of nasopharyngeal secretions. J Pediatr. 1973 Feb;82(2):297-9.

Budhiraja, S., Verma, R., Shields, M.D. (2012). The management of acute bronchiolitis in infants. Paidiatrics and Child Health, 23(7), 296-300.

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.

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. Review.

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.

American Academy of Pediatrics Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis. Pediatrics. 2006 Oct;118(4):1774-93.

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.

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.

Moore T. Suctioning techniques for the removal of respiratory secretions. Nurs Stand. 2003 Nov 12-18;18(9):47-53; quiz 54-5. Review. Erratum in: Nurs Stand. 2003 Dec 10-16;18(13):31.

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.

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. Review.

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.

Wai AK, Kwok WO, Chan MS, Graham CA, Rainer TH. Patients' perceptions of nasopharyngeal aspiration in the emergency department of a teaching hospital in Hong Kong. Emerg Med J. 2007 Jan;24(1):35-6.

• Responsible Party: Shabana Yusuf, Principal Investigator, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT02219334
• Other Study ID Numbers: H-33659
• First Posted: August 18, 2014
• Results First Posted: September 3, 2020
• Last Update Posted: September 3, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Shabana Yusuf, Baylor College of Medicine:

Children; Nasal suction devices; Suctioning

Additional relevant MeSH terms:

Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Infections