Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Bronchiolitis

Acute Bronchiolitis Clinical Trial

Official title:

Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Moderate and Severe Bronchiolitis; a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04245202
• Other study ID #: 17-TIP-012
• Status: Completed
• Phase: N/A
• Start date: March 14, 2017
• Est. completion date: March 10, 2020

Study information

• Verified date: February 2021
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to compare the efficacy of two different oxygenation methods on decrease respiratory rate, heart rate, and clinical respiratory score in children with moderate to severe bronchiolitis requiring oxygen therapy. 1. Standard face mask oxygen therapy (St-FMOT) 2. High-flow nasal cannula oxygen therapy (HFNCOT)

Description:

Bronchiolitis is the most common cause of hospitalization for children under one year of age and, caused by respiratory viruses. Although several medications and interventions studied for bronchiolitis treatment, hydration and oxygenation are the main treatments. High-flow nasal cannula oxygen therapy (HFNCOT) has been widely used to provide respiratory support in children with acute respiratory diseases. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

Inclusion Criteria:

• Children aged between 1-24 months applied with moderate and severe bronchiolitis requiring supplemental oxygen were eligible for the study.
• 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:

• Children admitted to the ICU for urgent invasive mechanical ventilation;
• 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.

Related Conditions & MeSH terms

• Acute Bronchiolitis
• Bronchiolitis

Intervention

Device:
• 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%.

Other:
• St-FMOT
The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation >92%.

Locations

Country	Name	City	State
Turkey	Ege University Medical Faculty	Izmir	Select A State

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (12)

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;(1):CD009609. doi: 10.1002/14651858.CD009609.pub2. Review. — View Citation

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. — View 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. Review. — View Citation

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 — View Citation

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 (p — View Citation

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. Review. — View Citation

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. — View Citation

Milési 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. Review. — View Citation

Milési 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, Re — View Citation

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. — View Citation

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. Review. — View Citation

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 — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis)	The time that heart rate takes into the normal range for age between the groups (Per-protocol analysis).	through study completion, an average of 96 hours
Primary	Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis)	The time that the respiratory rate takes into the normal range for age between the groups (Per-protocol analysis).	through study completion, an average of 96 hours
Primary	Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)	Unabbreviated scale title: Clinical Respiratory Score (Per-protocol analysis). The time that takes from severe bronchiolitis (9-12 points) to moderate bronchiolitis (5-8 points) or from moderate bronchiolitis (5-8 points) to mild bronchiolitis (0-4 points) between the groups. Higher scores mean a worse outcome. The score ranges from 0-12.	through study completion, an average of 96 hours
Secondary	Heart Rate (Intention-to-treat Analysis)	Any differences in the time any recorded changes in heart rate from randomization to the patients' discharge within the groups and between the groups (Intention-to-treat analysis).	Baseline, 1,2,4,12,24,48,72 and 96 hours
Secondary	Heart Rate (Per-protocol Analysis)	Any differences in the time any recorded changes in heart rate from randomization to the patients' discharge within the groups and between the groups (Per-protocol analysis).	Baseline, 1,2,4,12,24,48,72 and 96 hours
Secondary	Respiratory Rate (Intention-to-treat Analysis)	Any differences in the time any recorded changes in respiratory rate from randomization to the patients' discharge within the groups and between the groups (Intention-to-treat analysis).	Baseline, 1,2,4,12,24,48,72 and 96 hours
Secondary	Respiratory Rate (Per-protocol Analysis)	Any differences in the time any recorded changes in respiratory rate from randomization to the patients' discharge within the groups and between the groups (Per-protocol analysis).	Baseline, 1,2,4,12,24,48,72 and 96 hours
Secondary	Clinical Respiratory Score (Intention-to-treat Analysis)	Unabbreviated scale title: Clinical Respiratory Score (Intention-to-treat analysis) Any differences in the time any recorded changes in the clinical respiratory score from randomization to the patients' discharge within the groups and between the groups.; This clinical respiratory score includes respiratory rate, retraction, dyspnea/consciousness status, and wheezing.; The severity of parameters is scored 0 to 3 points, and the patients with a clinical respiratory score of 0-4 points were defined as mild, moderate (5-8 points), and severe (9-12 point) bronchiolitis. Higher scores mean a worse outcome. The score ranges from 0-12.	Baseline, 1,2,4,12,24,48,72 and 96 hours
Secondary	Clinical Respiratory Score (Per-protocol Analysis)	Unabbreviated scale title: Clinical Respiratory Score (Per-protocol analysis). Any differences in the time any recorded changes in the clinical respiratory score from randomization to the patients' discharge within the groups and between the groups. This clinical respiratory score includes respiratory rate, retraction, dyspnea/consciousness status, and wheezing. The severity of parameters is scored 0 to 3 points, and the patients with a clinical respiratory score of 0-4 points were defined as mild, moderate (5-8 points), and severe (9-12 point) bronchiolitis. Higher scores mean a worse outcome. The score ranges from 0-12.	Baseline, 1,2,4,12,24,48,72 and 96 hours
Secondary	Oxygen Requirement (Intention-to-treat Analysis)	The total duration of oxygen therapy (Intention-to-treat analysis).	through study completion, an average of 168 hours
Secondary	Oxygen Requirement (Per-protocol Analysis)	The total duration of oxygen therapy (Per-protocol analysis).	through study completion, an average of 168 hours
Secondary	Length of Hospital Stay (Intention-to-treat Analysis)	The time from randomization to the patient's discharge (Intention-to-treat analysis).	through study completion, an average of 168 hours
Secondary	Length of Hospital Stay (Per-protocol Analysis)	The time from randomization to the patient's discharge (Per-protocol analysis).	through study completion, an average of 168 hours
Secondary	Treatment Failure at 4 Hours (Intention-to-treat Analysis)	The number of treatment failures at 4 hours in each study arm (Intention-to-treat analysis).	4 hours
Secondary	Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis).	The number of participants admitted to the intensive care unit for invasive mechanical ventilation (Intention-to-treat analysis).	through study completion, an average of 168 hours
Secondary	Adverse Events of Therapy (Intention-to-treat Analysis)	The number of participants with any adverse events in therapy groups (Intention-to-treat analysis).	through study completion, an average of 168 hours