Comparison of High Flow Nasal Cannula and Standard Face Mask Oxygen Therapy in Children With Moderate and Severe Bronchiolitis; a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%.
排除标准
- •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.
研究组 & 干预措施
Active Comparator: HFNCOT
Set between 2 to 25 l/min, adjusted to obtain peripheral oxygen saturation >92%.
干预措施: HFNCOT (Device)
Active Comparator: St-FMOT
To obtain oxygen saturation >92%
干预措施: St-FMOT (Other)
结局指标
主要结局
Time Taken to Regress A Lower Clinical Respiratory Score (Per-protocol Analysis)
时间窗: 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)
时间窗: 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)
时间窗: 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).
次要结局
- 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 (Per-protocol Analysis)(Baseline, 1,2,4,12,24,48,72 and 96 hours)
- Clinical Respiratory Score (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)
- Oxygen Requirement (Per-protocol Analysis)(through study completion, an average of 168 hours)
- Oxygen Requirement (Intention-to-treat Analysis)(through study completion, an average of 168 hours)
- Length of Hospital Stay (Intention-to-treat Analysis)(through study completion, an average of 168 hours)
- Adverse Events of Therapy (Intention-to-treat Analysis)(through study completion, an average of 168 hours)
- Respiratory Rate (Intention-to-treat Analysis)(Baseline, 1,2,4,12,24,48,72 and 96 hours)
- Length of Hospital Stay (Per-protocol Analysis)(through study completion, an average of 168 hours)
- Treatment Failure at 4 Hours (Intention-to-treat Analysis)(4 hours)
- Pediatric Intensive Care Unit Admission (Intention-to-treat Analysis).(through study completion, an average of 168 hours)
研究者
Aykut Eşki
Medical Doctor, Pediatric Pulmonology
Ege University