N/A
N=87
Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Bronchiolitis
Acute Bronchiolitis
Bottom Line
View on ClinicalTrials.gov: NCT04245202 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis) — 12; 2 hour — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HFNCOT (Device); St-FMOT (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Ege University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Taken to Reach the Normal Range for Heart Rate (Per-protocol Analysis) |
12; 2 | <0.001 sig |
| PRIMARY Time Taken to Reach the Normal Range for Respiratory Rate (Per-protocol Analysis) |
24; 4 | <0.001 sig |
| PRIMARY Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis) |
4; 2 | 0.003 sig |
| SECONDARY Heart Rate (Intention-to-treat Analysis) |
172.90; 171.05; 166.21; 151.28; 164.00; 146.59 | <0.001 sig |
| SECONDARY Heart Rate (Per-protocol Analysis) |
169.03; 170.37; 160.76; 150.37; 157.58; 145.39 | <0.001 sig |
| SECONDARY Respiratory Rate (Intention-to-treat Analysis) |
65.08; 66.71; 60.20; 56.84; 57.45; 51.10 | <0.001 sig |
| SECONDARY Respiratory Rate (Per-protocol Analysis) |
65.52; 66.68; 59.50; 56.60; 55.34; 50.65 | 0.003 sig |
| SECONDARY Clinical Respiratory Score (Intention-to-treat Analysis) |
9.0; 10.0; 8.0; 7.0; 8.0; 6.0 | 0.002 sig |
| SECONDARY Clinical Respiratory Score (Per-protocol Analysis) |
9.0; 9.5; 8.0; 7.0; 7.0; 6.0 | 0.001 sig |
| SECONDARY Oxygen Requirement (Intention-to-treat Analysis) |
29.5; 19.0 | — |
| SECONDARY Oxygen Requirement (Per-protocol Analysis) |
24.0; 18.5 | 0.08 |
| SECONDARY Length of Hospital Stay (Intention-to-treat Analysis) |
5.5; 5.0 | 0.22 |
| SECONDARY Length of Hospital Stay (Per-protocol Analysis) |
5; 5 | 0.99 |
| SECONDARY Treatment Failure at 4 Hours (Intention-to-treat Analysis) |
10; 1 | 0.02 sig |
| SECONDARY Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis). |
10; 1 | 0.02 sig |
| SECONDARY Adverse Events of Therapy (Intention-to-treat Analysis) |
1; 5 | 0.08 |
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)
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04245202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.