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

Study Overview
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Brief Summary
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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. Standard face mask oxygen therapy (St-FMOT) High-flow nasal cannula oxygen therapy (HFNCOT)

Detailed Description
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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.

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

Conditions
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Acute Bronchiolitis

Intervention / Treatment
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* Device: HFNCOT
* Other: St-FMOT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator: HFNCOT<br>Set between 2 to 25 l/min, adjusted to obtain peripheral oxygen saturation >92%. | Device: HFNCOT<br>* 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%.<br>|
| Active Comparator: Active Comparator: St-FMOT<br>To obtain oxygen saturation >92% | Other: St-FMOT<br>* The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation >92%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Oxygen Requirement (Intention-to-treat Analysis) | The total duration of oxygen therapy (Intention-to-treat analysis). | through study completion, an average of 168 hours | 
| Oxygen Requirement (Per-protocol Analysis) | The total duration of oxygen therapy (Per-protocol analysis). | through study completion, an average of 168 hours | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Bronchiolitis, High Flow Nasal Cannula, Standard Face Mask