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

Ege University87 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Bronchiolitis

Interventions

HFNCOTDEVICE

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-FMOTOTHER

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

Eligibility

Sex: ALLMin age: 1 MonthMax age: 24 Months

Medical Language ↔ Plain English

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.

Locations (1)

Ege University Medical Faculty

Izmir, Select A State, Turkey (Türkiye)

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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.

Time frame: through study completion, an average of 96 hours

Secondary Outcomes

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).

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

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).

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

Respiratory Rate (Intention-to-treat Analysis)

Data from ClinicalTrials.gov

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