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

NCT04245202 | Completed Results

• 1 other identifier: 17-TIP-012
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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. 1.Standard face mask oxygen therapy (St-FMOT)
2. 2.High-flow nasal cannula oxygen therapy (HFNCOT)

Conditions

Acute Bronchiolitis

Keywords

Acute Bronchiolitis; High Flow Nasal Cannula; Standard Face Mask

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (13)

• Heart Rate (Intention-to-treat Analysis)

  Baseline, 1,2,4,12,24,48,72 and 96 hours

• Heart Rate (Per-protocol Analysis)

  Baseline, 1,2,4,12,24,48,72 and 96 hours

• Respiratory Rate (Intention-to-treat Analysis)

  Baseline, 1,2,4,12,24,48,72 and 96 hours

• Respiratory Rate (Per-protocol Analysis)

  Baseline, 1,2,4,12,24,48,72 and 96 hours

• Clinical Respiratory Score (Intention-to-treat Analysis)

  Baseline, 1,2,4,12,24,48,72 and 96 hours

Study Arms (2)

Active Comparator: HFNCOT

ACTIVE COMPARATOR

Set between 2 to 25 l/min, adjusted to obtain peripheral oxygen saturation \>92%.

Device: HFNCOT

Active Comparator: St-FMOT

ACTIVE COMPARATOR

To obtain oxygen saturation \>92%

Other: St-FMOT

Interventions

HFNCOT DEVICE

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: HFNCOT

St-FMOT OTHER

The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation \>92%.

Active Comparator: St-FMOT

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Medical Faculty

Izmir, Select A State, 35100, Turkey (Türkiye)

Location

Related Publications (13)

• 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.

  PMID: 29562151 RESULT

• 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.

  PMID: 26572729 RESULT

• 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.

  PMID: 28353318 RESULT

• 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.

  PMID: 24846750 RESULT

• 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.

  PMID: 23900520 RESULT

• 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.

  PMID: 30343318 RESULT

• 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.

  PMID: 28903952 RESULT

• 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.

  PMID: 24912486 RESULT

• 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.

  PMID: 25593745 RESULT

• 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.

  PMID: 27062623 RESULT

• 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 RESULT

• 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.

  PMID: 24442856 RESULT

• 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.

  PMID: 35293153 DERIVED

Limitations and Caveats

The study was performed in a single center and had a limited sample size. We did not blind the allocation of oxygen therapies to introduce the risk of performance bias. We did not reach the number of participants calculated with the power analysis because of the financial support problem. Therefore, we used effect size for each of the primary outcomes. Patients were not allocated to receive therapy in a ratio of 1:1. Hence, a numerical difference occurred between the two groups.

Results Point of Contact

• Title: Dr. Aykut Eşki
• Organization: Ege University Medical Faculty Hospital

aykuteski1984@gmail.com

05303009760

Study Officials

• Aykut Eşki, MD

  Ege University Medical Study

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Medical Doctor, Pediatric Pulmonology

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 28, 2020
• Study Start: March 14, 2017
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: February 16, 2021
• Results First Posted: February 16, 2021

Record last verified: 2021-02

Locations

TU (1)