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

Not Applicable

Completed

Conditions: Acute Bronchiolitis

Interventions: Other: St-FMOT
Device: HFNCOT

Registration Number: NCT04245202

Lead Sponsor: Ege University

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. Standard face mask oxygen therapy (St-FMOT)

2. High-flow nasal cannula oxygen therapy (HFNCOT)

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 87

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: St-FMOT	St-FMOT	To obtain oxygen saturation \>92%
Active Comparator: HFNCOT	HFNCOT	Set between 2 to 25 l/min, adjusted to obtain peripheral oxygen saturation \>92%.

Primary Outcome Measures

Name	Time	Method
Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)	through study completion, an average of 96 hours	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 Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis)	through study completion, an average of 96 hours	The time that the respiratory rate takes into the normal range for age between the groups (Per-protocol analysis).
Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis)	through study completion, an average of 96 hours	The time that heart rate takes into the normal range for age between the groups (Per-protocol analysis).

Secondary Outcome Measures

Name	Time	Method
Respiratory Rate (Per-protocol Analysis)	Baseline, 1,2,4,12,24,48,72 and 96 hours	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).
Clinical Respiratory Score (Per-protocol Analysis)	Baseline, 1,2,4,12,24,48,72 and 96 hours	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.
Heart Rate (Per-protocol Analysis)	Baseline, 1,2,4,12,24,48,72 and 96 hours	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).
Clinical Respiratory Score (Intention-to-treat Analysis)	Baseline, 1,2,4,12,24,48,72 and 96 hours	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.
Oxygen Requirement (Per-protocol Analysis)	through study completion, an average of 168 hours	The total duration of oxygen therapy (Per-protocol analysis).
Oxygen Requirement (Intention-to-treat Analysis)	through study completion, an average of 168 hours	The total duration of oxygen therapy (Intention-to-treat analysis).
Length of Hospital Stay (Intention-to-treat Analysis)	through study completion, an average of 168 hours	The time from randomization to the patient's discharge (Intention-to-treat analysis).
Adverse Events of Therapy (Intention-to-treat Analysis)	through study completion, an average of 168 hours	The number of participants with any adverse events in therapy groups (Intention-to-treat analysis).
Respiratory Rate (Intention-to-treat Analysis)	Baseline, 1,2,4,12,24,48,72 and 96 hours	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).
Length of Hospital Stay (Per-protocol Analysis)	through study completion, an average of 168 hours	The time from randomization to the patient's discharge (Per-protocol analysis).
Treatment Failure at 4 Hours (Intention-to-treat Analysis)	4 hours	The number of treatment failures at 4 hours in each study arm (Intention-to-treat analysis).
Heart Rate (Intention-to-treat Analysis)	Baseline, 1,2,4,12,24,48,72 and 96 hours	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).
Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis).	through study completion, an average of 168 hours	The number of participants admitted to the intensive care unit for invasive mechanical ventilation (Intention-to-treat analysis).