Effects of Nasal High Flow Therapy on Ventilation and Gas Exchange During Wakefulness and Sleep in Healthy Newborn Babies in a Randomized Crossover Study Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change of minute ventilation
研究概览
简要总结
Nasal High Flow (NHF) and CPAP are established forms of respiratory support in neonates and often produce similar clinical outcomes. It has been shown in adults that NHF produce different effects on ventilation during wakefulness and sleep. There is no physiological data on effects of NHF in neonates. The physiological effects may be impacted by sleep/awake status.
详细描述
The aim of the study to investigate the effects of NHF therapy on ventilation and gas exchange during wakefulness and sleep in healthy term newborns.
Interventions:
NHF will be applied at 8 L/min (AIRVO 2) via (OPT 316) Optiflow nasal cannula interface without supplemental oxygen. Participants will act as their own control (no intervention) in a randomized crossover study design.
Physiological measurements:
- Ventilation will be assessed using Respiratory Inductance Plethysmography (RIP) (Respitrace QDC, Viasys, USA).
- Blood carbon dioxide (CO2) and oxygen levels will be measured by a non-invasive transcutaneous monitor (Tosca, Radiometer, Demnark).
- All experiment will be recorded using Analogue-to-Digital converter (Powerlab, ADInstruments, New Zealand) and LabChart software with video recording of the patient.
- Sleep/awake statuss will be determined by videorecording of the patient and Electroencephalogram (EEG) (Alice Polysomnography System Philips, USA)
- The total study time will be <3 hours in total for each participant. Routine measurement of heart rate, respiratory rate and oxygen saturation will be performed as per standard neonatal clinical practice.
- Intervention can be terminated if at any time SpO2 drops below 80%, TcCO2 increases above 60 mm Hg, Respiratory Rate increases above 80 breaths per min for more than one minute).
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 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy full or near full-term newborns of 1-2 days of age.
- •A parent has given written informed consent to their baby's participation.
排除标准
- •Infants who are clinically unstable and unsuitable for non-invasive respiratory support as judged by consultant clinician or required supplemental oxygen.
- •Known upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly.
- •A parent has not given written informed consent.
研究组 & 干预措施
Nasal High Flow
NHF will be applied at 8 L/min (AIRVO 2) through (OPT 316) Optiflow nasal cannula interface without supplemental oxygen
干预措施: Nasal High Flow (Device)
Control
Control is no NHF intervention
结局指标
主要结局
Change of minute ventilation
时间窗: Up to 1 hour
Change of minute ventilation measured with calibrated Respiratory Inductance Plethysmography
Change of respiratory rate
时间窗: Up to 1 hour
Change of respiratory rate measured with Respiratory Inductance Plethysmography
次要结局
- Tissue oxygen(Up to 1 hour)
- Tissue carbon dioxide(Up to 1 hour)
- Heart rate(Up to 1 hour)
- Oxygen saturation(Up to 1 hour)