Neonatal Mask Seal; a Randomised Controlled Trial of Two-handed Versus One-handed Hold for Delivering Positive-pressure Ventilation With a Facemask in Preterm and Term Infants: The NeoSeal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Mask leak
研究概览
简要总结
When babies can't breathe effectively, we can use a facemask to give them breaths and oxygen. The mask can be held with one or two hands, depending on the preference of the doctor. Both types of mask holds are recommended in international guidelines, but it is unclear which one is better for the baby. If a lot of air is leaking around the mask, it means that the baby is not getting the full breathing support that the healthcare providers are trying to give. There currently is not enough evidence to say which type of hold is better to reduce this potential leaking of air.
In this study, the investigators will compare two different ways of holding a mask on a baby's face to help them breathe. Each baby will be randomly allocated to either a one-handed or a two-handed mask hold, and the investigators will measure how much air leaks out around the mask during each breath. Any baby in the neonatal unit may be included in this study.
详细描述
This study will compare the measured leak in mask ventilation delivered by a healthcare professional in the neonatal team, using a one-handed versus a two-handed hold with a standardised mask size and shape. This is to assess the two-handed technique as a potential first-line approach in neonatal bag-mask ventilation.
The handholds will be assessed by a randomised controlled trial, with the two-handed hold as the intervention and the one-handed hold as the control.
The population that will be studied is neonates in the neonatal intensive care unit (NICU), at any gestation, who the clinical team have decided to intubate.
A member of the research team, who will provide an out-of-hours on call service, will attend the event. The relevant outcomes will be measured by the Monivent Neo100, which will be set up by the research team. Standardised masks, as used per local protocol, will be used, with the sensor module placed between that and the T-piece with an adaptor.
The outcomes will assess the effectiveness of both the intervention and control, including ventilation parameters recorded by the Monivent Neo100 and the clinical stability of the patient. The primary outcome of this study is the percentage mask leak.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
This is an unblinded study as it is not possible to blind the provider to the type of mask hold. However, the operators will be blinded to the respiratory function monitor measurements feedback. This will be achieved by obscuring the colour sensor with brown, opaque tape and covering the Monivent screen. The outcome assessor will be blinded to the group allocation.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All term and preterm neonates in the neonatal unit who the clinical team have decided to intubate, with or without pre-medication and who require mask ventilation prior to intubation attempt.
排除标准
- •Neonates with a congenital malformation that would impact mask seal will not be included.
研究组 & 干预措施
Intervention: Two-handed facemask hold
Two-handed mask hold technique while giving facemask ventilation, with another operator designated to deliver positive inspiratory pressure (PIP) via the T-piece. The operators may be any member of the neonatal team, who have undergone Neonatal Resusctiation Programme (NRP) certification. Standardised mask size and shape for gestation and weight, as per local policy, will be used.
干预措施: Two-handed facemask hold (Procedure)
Control: One-handed facemask hold
One-handed mask hold technique while giving facemask ventilation, with the same operator holding the mask and delivering positive pressure ventilation (PPV) via the T-piece.
干预措施: Control: One-handed facemask hold (Procedure)
结局指标
主要结局
Mask leak
时间窗: Over a maximum of 20 minutes
Mask leak percentage, as measured by the Monivent Respiratory Function Monitor (RFM). Collected over a minimum of 5 breaths. Maximum of 2 episodes of facemask ventilation will be collected, with values averaged.
次要结局
- Lowest oxygen saturation(Over a maximum of 20 minutes)
- Highest supplemental FiO2 used during facemask ventilation(Over a maximum of 20 minutes)
- Positive inspiratory pressure during facemask ventilation(Over a maximum of 20 minutes)
- Percentage of obstructed breaths during facemask ventilation(Over a maximum of 20 minutes)
- Tidal volume during facemask ventilation(Over a maximum of 20 minutes)
- Number of times facemask position is adjusted during facemask ventilation(Over a maximum of 20 minutes)
- Duration of facemask ventilation(Over a maximum of 20 minutes)
- Crossover to other handhold(Over a maximum of 20 minutes)
- User opinion of mask hold(Over a maximum of 20 minutes)
- Lowest heart rate(Over a maximum of 20 minutes)