Effect of Cannula Size on Peripheral Oxygen Saturation During Nasal High Flow Therapy in Neonates With Respiratory Distress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Peripheral oxygen saturation (SpO2 )
研究概览
简要总结
Treatment with nasal high flow therapy (NHF) is an increasingly popular method of respiratory support in newborns.
Safe and effective use of NHF requires selection of an appropriate nasal prong-to-nares ratio because leak can influence the delivered pressure.
To the best of our knowledge, this is the first study to investigate the effect of using different NHF cannula size on peripheral oxygen saturation in newborns with respiratory distress.
详细描述
NHF will be applied at 8 L/min using the AIRVO 2 through smaller and larger Optiflow nasal cannula. The study will have a randomized crossover design. The larger or smaller cannula size will be applied as the first intervention during each experiment. During each experiment, if the larger cannula is applied first, then the smaller cannula will be applied second and if the smaller cannula is applied first, then the larger cannula will be applied second. Each experiment will last for 1.5 hour.
- During baseline, supplemental oxygen will be added during NHF therapy to keep SpO2 in normal ranges (90%-94%). When the SpO2 has stabilized then the level of supplemental oxygen will be set for the entire experiment unless there is a significant change in SpO2 as determined by the attending consultant.
- There will be three consecutive 30-min periods of recording during each experiment and each experiment will last approximately 1.5 hour.
- Ventilation will be assessed by Respiratory Inductance Plethysmography (Respitrace) and transcutaneous carbon dioxide and oxygen.
- Recordings will be made using ADInstruments Powerlab and Labchart software with video recording of the patient.
- Routine measurement of heart rate, respiratory rate and oxygen saturations will be performed as per standard neonatal practice.
The researcher is an experienced neonatal consultant who will be directly observing the baby throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Term and near term newborns with respiratory distress receiving treatment with NHF
- •≤ 48 hours old
- •Written parental informed consent
排除标准
- •Infants who are clinically unstable and unsuitable for non-invasive respiratory support as judged by consultant clinician (meet nHF failure criteria).
- •Known major upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly
- •A parent has not given written informed consent to their baby's participation.
- •Prior intubation and/or surfactant administration
- •Known or suspected hypoxic ischemic encephalopathy
结局指标
主要结局
Peripheral oxygen saturation (SpO2 )
时间窗: 1.5 hour
The difference in SpO2 between the period of using the larger cannula versus the smaller cannula
次要结局
- Pulse rate(1.5 hour)
- Relative minute ventilation(1.5 hour)
- Transcutaneous oxygen(1.5 hour)
- inspiratory effort(1.5 hour)
- Respiratory rate(1.5 hour)
- Transcutaneous carbon dioxide(1.5 hour)
研究者
Pavel Mazmanyan
Professor
Erebouni Medical Center