Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Bronchiolitis
NCT ID: NCT04245202
Last Updated: 2021-02-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
87 participants
INTERVENTIONAL
2017-03-14
2020-03-10
Brief Summary
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1. Standard face mask oxygen therapy (St-FMOT)
2. High-flow nasal cannula oxygen therapy (HFNCOT)
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Detailed Description
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Patients had earlier improvement with HFNCOT to decrease the respiratory rate and respiratory effort than patients with standard low-flow oxygen therapy (SOT).
HFNCOT therapy reduced more effective in heart rate, respiratory effort, and length of supportive oxygen treatment (LOOT) compared with SOT. However, the length of hospital stay (LOS) and feeding ability had better consequences in patients with moderate and severe bronchiolitis treated with HFNCOT.
Another published study shows that in infants with acute bronchiolitis, which required oxygen therapy, there was no significant difference between therapy groups in terms of LOOT, LOS, and admission to the intensive care unit (ICU). HFNCOT was more efficient than SOT and reduced the rate of intubation/invasive ventilation in severe bronchiolitis management. Despite these beneficial effects of HFNCOT, it was not recommended by international guidelines yet. However, well designed, prospective randomized controlled trials are still needed to use this therapy in the wards.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active Comparator: HFNCOT
Set between 2 to 25 l/min, adjusted to obtain peripheral oxygen saturation \>92%.
HFNCOT
The patient will receive a high flow nasal of humidified oxygen, set between 2 to 25 l/min. The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation \>92%.
Active Comparator: St-FMOT
To obtain oxygen saturation \>92%
St-FMOT
The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation \>92%.
Interventions
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HFNCOT
The patient will receive a high flow nasal of humidified oxygen, set between 2 to 25 l/min. The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation \>92%.
St-FMOT
The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation \>92%.
Eligibility Criteria
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Inclusion Criteria
* The severity of bronchiolitis was assessed according to the clinical respiratory score (CRS) of Liu et al. (5). The patients with CRS ≥5 were included.
* Peripheral oxyhemoglobin saturation is \< 92%.
Exclusion Criteria
* those who received standard oxygen therapy (SOT) or HFNCOT at other facilities before arrival;
* those with an underlying medical condition (such as congenital heart disease, chronic lung disease, neuromuscular disease, metabolic disease, or immunocompromised);
* those who had a craniofacial malformation, an upper airway obstruction, pneumothorax, or nasal trauma, and missing parental consent or a refused permission of the participant.
1 Month
24 Months
ALL
No
Sponsors
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Ege University
OTHER
Responsible Party
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Aykut Eşki
Medical Doctor, Pediatric Pulmonology
Principal Investigators
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Aykut Eşki, MD
Role: PRINCIPAL_INVESTIGATOR
Ege University Medical Study
Locations
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Ege University Medical Faculty
Izmir, Select A State, Turkey (Türkiye)
Countries
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References
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Franklin D, Babl FE, Schlapbach LJ, Oakley E, Craig S, Neutze J, Furyk J, Fraser JF, Jones M, Whitty JA, Dalziel SR, Schibler A. A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis. N Engl J Med. 2018 Mar 22;378(12):1121-1131. doi: 10.1056/NEJMoa1714855.
Franklin D, Dalziel S, Schlapbach LJ, Babl FE, Oakley E, Craig SS, Furyk JS, Neutze J, Sinn K, Whitty JA, Gibbons K, Fraser J, Schibler A; PARIS and PREDICT. Early high flow nasal cannula therapy in bronchiolitis, a prospective randomised control trial (protocol): A Paediatric Acute Respiratory Intervention Study (PARIS). BMC Pediatr. 2015 Nov 14;15:183. doi: 10.1186/s12887-015-0501-x.
Liu G, Fan C, Wu H. High-flow nasal cannula therapies for respiratory management in pediatric patients. Minerva Pediatr. 2018 Oct;70(5):488-492. doi: 10.23736/S0026-4946.17.04781-8. Epub 2017 Mar 27.
Pham TM, O'Malley L, Mayfield S, Martin S, Schibler A. The effect of high flow nasal cannula therapy on the work of breathing in infants with bronchiolitis. Pediatr Pulmonol. 2015 Jul;50(7):713-20. doi: 10.1002/ppul.23060. Epub 2014 May 21.
Bressan S, Balzani M, Krauss B, Pettenazzo A, Zanconato S, Baraldi E. High-flow nasal cannula oxygen for bronchiolitis in a pediatric ward: a pilot study. Eur J Pediatr. 2013 Dec;172(12):1649-56. doi: 10.1007/s00431-013-2094-4. Epub 2013 Jul 31.
Milesi C, Pierre AF, Deho A, Pouyau R, Liet JM, Guillot C, Guilbert AS, Rambaud J, Millet A, Afanetti M, Guichoux J, Genuini M, Mansir T, Bergounioux J, Michel F, Marcoux MO, Baleine J, Durand S, Durand P, Dauger S, Javouhey E, Leteurtre S, Brissaud O, Renolleau S, Portefaix A, Douillard A, Cambonie G; GFRUP Respiratory Study Group. A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2). Intensive Care Med. 2018 Nov;44(11):1870-1878. doi: 10.1007/s00134-018-5343-1. Epub 2018 Oct 21.
Mace AO, Gibbons J, Schultz A, Knight G, Martin AC. Humidified high-flow nasal cannula oxygen for bronchiolitis: should we go with the flow? Arch Dis Child. 2018 Mar;103(3):303. doi: 10.1136/archdischild-2017-313950. Epub 2017 Sep 13. No abstract available.
Testa G, Iodice F, Ricci Z, Vitale V, De Razza F, Haiberger R, Iacoella C, Conti G, Cogo P. Comparative evaluation of high-flow nasal cannula and conventional oxygen therapy in paediatric cardiac surgical patients: a randomized controlled trial. Interact Cardiovasc Thorac Surg. 2014 Sep;19(3):456-61. doi: 10.1093/icvts/ivu171. Epub 2014 Jun 8.
Milesi C, Boubal M, Jacquot A, Baleine J, Durand S, Odena MP, Cambonie G. High-flow nasal cannula: recommendations for daily practice in pediatrics. Ann Intensive Care. 2014 Sep 30;4:29. doi: 10.1186/s13613-014-0029-5. eCollection 2014.
Schibler A, Franklin D. Respiratory support for children in the emergency department. J Paediatr Child Health. 2016 Feb;52(2):192-6. doi: 10.1111/jpc.13078.
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.
Beggs S, Wong ZH, Kaul S, Ogden KJ, Walters JA. High-flow nasal cannula therapy for infants with bronchiolitis. Cochrane Database Syst Rev. 2014 Jan 20;2014(1):CD009609. doi: 10.1002/14651858.CD009609.pub2.
Eski A, Ozturk GK, Turan C, Ozgul S, Gulen F, Demir E. High-flow nasal cannula oxygen in children with bronchiolitis: A randomized controlled trial. Pediatr Pulmonol. 2022 Jun;57(6):1527-1534. doi: 10.1002/ppul.25893. Epub 2022 Mar 28.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17-TIP-012
Identifier Type: -
Identifier Source: org_study_id
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