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

NCT02219334 | Terminated Results FDA Device

• 1 other identifier: H-33659
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

Children; Nasal suction devices; Suctioning

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (2)

• Percentage of Patients Readmitted Within 48 Hours of Discharge.

  within 48 hours of discharge

• 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

Study Arms (2)

NoseFrida

EXPERIMENTAL

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

NeoSucker

NO INTERVENTION

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.

Interventions

NoseFrida DEVICE

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.

NoseFrida

Eligibility Criteria

• Age: 2 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (13)

• Benincaso FV, Smith MH. A suction-controlled nasal aspirator for collection of nasopharyngeal secretions. J Pediatr. 1973 Feb;82(2):297-9. doi: 10.1016/s0022-3476(73)80175-1. No abstract available.

  PMID: 4684375 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 17947838 BACKGROUND

• 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.

  PMID: 23809346 BACKGROUND

• 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.

  PMID: 14670770 BACKGROUND

• Diagnosis and Managment of Bronchiolitis., 2006. Subcommittee on Diagnosis and Management of Bronchiolitis. 118, 1774.

  BACKGROUND

• 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.

  PMID: 19196675 BACKGROUND

• 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.

  PMID: 24333327 BACKGROUND

• 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.

  PMID: 14649194 BACKGROUND

• 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.

  PMID: 23460088 BACKGROUND

• 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.

  PMID: 22734014 BACKGROUND

• 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.

  PMID: 21088635 BACKGROUND

• 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. doi: 10.1136/emj.2006.039701.

  PMID: 17183041 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The sample size was small and was a convenience sample. Not all parents participated in the satisfaction survey. The lack of documentation of nose bleeds and nasal swelling does not suggest the absence of these minor side effects.

Results Point of Contact

• Title: Shabana Yusuf/Associate Professor of Pediatrics
• Organization: Baylor College of Medicine

syusuf@bcm.edu

832-824-5388

Study Officials

• Elizabeth L Watson, MSN, RN, CNL

  Baylor College of Medicine

  STUDY DIRECTOR

• Aderonke Adekunle-Ojo, MD

  Baylor College of Medicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2014
• First Posted: August 18, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 3, 2020
• Results First Posted: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)