Study of Nasopharyngeal Pressures, Tidal Breathing Indices and Inspired Gas Concentrations During High Flow Nasal Cannula (HFNC) and CPAP Treatment in Neonates
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Nasopharyngeal pressures (pressures in upper breathing passages) generated by HFNC at flow rate range of 2 to 8 L/min.
研究概览
简要总结
The most commonly used noninvasive respiratory support in preterm babies is Continuous Positive Airway Pressure (CPAP), which provides extra breathing support to babies who are breathing by themselves). Increasingly High flow Nasal Cannula (HFNC, newer form of extra breathing support) therapy has found its way in clinical practice despite lack of good physiological data. There are also concerns about its potential to generate higher pressures in airways which can cause over distension of lungs.
We would like to find out the effects of HFNC on
-
- Airway pressures in various flow rates and in comparison to CPAP.
-
- Breathing markers including respiratory rate (speed of breathing), oxygen and carbon dioxide levels, tidal volumes (how much air breathed in with each breath) and airway wash out (wash out of waste gas from the airway).
We plan to study 15 babies each in three different weight categories supported with either CPAP or HFNC. The airway pressures, oxygen and carbon dioxide concentration in airway are measured by a small plastic catheter (similar to feeding tube but much shorter in length), carbon dioxide levels by skin sensors, how fast and how much babies breathe by a special vest applied like a layer of clothing. These will be recorded both on HFNC and CPAP. There are no blood tests or invasive procedures involved. The baby will be monitored throughout the study period of approximately two hours by experienced registrar who is trained to use the study device.
This study will improve our understanding of physiological effects of HFNC and lead to better care of preterm babies.
详细描述
Purpose and design
Design: Prospective randomised crossover study.
Purpose:
- Raising airway pressure is one of the most important interventions at the disposal of clinicians treating patients with respiratory failure. In premature infants Continuous Positive Airway Pressure (CPAP) and High Flow Nasal Cannula (HFNC) are noninvasive techniques to raise mean airway pressure when intubation is not required. It is not clear how clinicians choose between these techniques and there is little data comparing the physiological effect of these treatments.
- A composite physiological assessment of babies on HFNC and CPAP treatment is required to understand how HFNC works. It is important to answer this question to understand how best to use HFNC in babies.
- This proposal is designed to provide information on physiological effects of both therapies in same population of babies across different weight categories. The study protocol involves use of same HFNC device that is currently being used in neonatal unit.
Interventions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 5 Days 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They are less than 37 weeks' gestation at birth and more than 5 days of age
- •Are on non-invasive respiratory support and
- •The parent(s) have 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 attending neonatology consultant clinician.
- •Participation in a concurrent study that prohibits inclusion in other trials
- •Known major upper airway, lower respiratory tract, cardiac or gastrointestinal tract anomaly
- •Current complications such as pneumothorax.
结局指标
主要结局
Nasopharyngeal pressures (pressures in upper breathing passages) generated by HFNC at flow rate range of 2 to 8 L/min.
时间窗: Primary outcome recorded during the measurement period of 2 hours.
The range of pressures generated during high flow nasal cannula treatment over flow rate range of 2 to 8 litres per minute will be recorded during the study period.
次要结局
- The relationship of flow and inspired oxygen concentration on actual laryngeal inspired and expired O2 and CO2 concentration in HFNC and CPAP.(Recorded during the 2 hour study period)
- Nasopharyngeal pressures (pressures in upper breathing passages) generated at CPAP of 6 cm of water(Pressures recorded during the study period of 2 hours)
- The effect of changing flow rate of HFNC on following physiological parameters Oxygen saturation and transcutaneous CO2, Respiratory rate, Tidal volume and FRC baseline change.(Recorded during the study period of 2 hours)