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临床试验/NCT06898801
NCT06898801尚未招募不适用

Neonatal INtubation After "Just-in-time" Audiovisual Training: a Randomised Controlled Trial

University College Dublin1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
140
试验地点
1
主要终点
Total laryngoscopy time in seconds

研究概览

简要总结

This research focuses on one of the most common problems in newborn medicine: breathing difficulties. Breathing problems are the most common reason for admission to our neonatal unit at the National Maternity Hospital. When a baby has serious breathing difficulty, inserting a breathing tube to place them on a ventilator can be lifesaving. A breathing tube must be placed through the vocal cords into the windpipe (trachea). A device called a laryngoscope is placed in a patients mouth to allow the doctor to see the vocal cords and insert the tube correctly.

The skill of placing this breathing tube (intubation) is important for doctors and specialists to learn so that they can confidently perform it in an emergency.

In the past, doctors had more opportunities during their training to learn and practice this with supervision from seniors. In recent years, babies, thankfully, need to be intubated less frequently and doctors working hours are better regulated. As a result, junior doctors have less chances to perform this skill. There is a need to improve how we teach the procedure of intubating babies to doctors in training to meet the needs of trainees today.

The investigators want to perform a study to help teach doctors in training how to perform intubation of a newborn using a video laryngoscope. The team are looking to assess if showing a short educational video to the doctor and team just before performing an intubation using a video laryngoscope will reduce the time the procedure takes. This is called a "Just-in-Time" video. The investigators aim to demonstrate a benefit by performing a randomised control trial. This means that when a baby requires intubation as decided by their treating doctors, the team will be randomly allocated to view a "Just-in-Time" video before performing the intubation or not. The investigators will then compare the two groups to see if there is a difference in the total time the procedure takes.

详细描述

Performing an urgent intubation on a critically ill newborn can be stressful and daunting. It is a vital, life-saving skill for not only neonatologists but paediatricians who may be faced with the rare scenario of an unwell newborn in respiratory distress. Neonatal intubation remains a mandatory competency of the higher speciality training scheme in General Paediatrics ( Royal College of Physicians of Ireland.) This is in line with paediatric training in the UK and Europe and neonatal intubation competency remains a concern not only in Ireland but worldwide. Teaching neonatal intubation via an apprenticeship model needs to be balanced with the need to minimise risk to babies of prolonged or repeated attempts. Paediatric and neonatal trainees can struggle to achieve competency in this skill as advances in perinatal care such as non-invasive ventilation, less invasive surfactant methods and avoidance of universal intubation for meconium have decreased the number of routine intubations performed. With greater numbers of doctors and advanced neonatal nurse practitioners and fewer working hours, the number of intubation opportunities for trainees continues to fall. Even for more experienced practitioners it can be challenging to maintain intubation competency.

The teaching of skills to paediatricians and neonatologists needs to adapt to the changing nature of training. "Just-in-Time" (JiT) educational interventions have been studied in a variety of simulated and clinical environments to improve training or increase success of uncommonly performed procedures by providing a brief educational intervention shortly before performing the procedure . A study by Gizicki et al applied this concept to neonatal intubation in the clinical setting. They randomised 65 residents performing intubation to receive a Just-in-Time manikin based low fidelity simulation session or a 5-minute video just before performing an intubation. They did not demonstrate a difference in overall intubation success rates between these groups although intubation success rates in both groups were higher than baseline. Intubation in this study was performed using both direct and video laryngoscopy. It has been demonstrated that video laryngoscopy (VL) improves neonatal intubation success, but the method of intubation differs from standard laryngoscopy and there is a learning curve for operators using this device initially. Given that video laryngoscopic intubation is likely to become the standard of care, there is a need to train operators to use this device correctly in order to benefit from its greater utility.

A recent study performed in the National Maternity Hospital by Ni Chathasaigh et al examined video recordings of neonatal intubations using VL. The VAN (Video laryngoscopic Analysis of Neonatal Intubations) study recorded the external environment in addition to the internal VL views of the baby's airway. Analysis of these videos highlights common features of successful and unsuccessful attempts. Using the lessons from the VAN study, the investigators propose a study of a novel "Just-in-Time" educational video to improve intubation performance by reducing the total time required from insertion of the laryngoscope to successful intubation. The "Just-in-Time" video will supplement an intubation checklist and will concentrate on the key aspects of intubation; anatomy, intubator position, cricoid pressure, laryngoscopic technique and supervisor instructions. The "Just-in-Time" video will be directed at the intubator, supervisor and assisting nurse.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
— 至 1 Year(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Neonates of any age or gestation who require endotracheal intubation in the Neonatal Intensive Care Unit in the National Maternity Hospital during the study period.

排除标准

  • •Neonates with an upper airway malformation.
  • •If it is deemed by the treating clinical team that the clinical scenario does not allow time for the intervention e.g. cardiac arrest

研究组 & 干预措施

Control

No Intervention

Intubation will be carried out as per current standard practice with supervision of trainee by senior clinician or initial intubation by senior clinician.

Just-in-Time Intervention

Experimental

The primary intubator, supervising clinician and intubation assistant or nurse will view the brief "Just-in-time" video once, immediately prior to performing the intubation with a video laryngoscope. The decision to intubate an infant and who will perform the intubation will be made by the clinical team. Other aspects of the procedure, for example premedications, use of pre-intubation checklist will not change from standard practice.

干预措施: Just-in-time video training (Other)

结局指标

主要结局

Total laryngoscopy time in seconds

时间窗: 24 months

An intubation attempt is defined as the introduction of the laryngoscope blade into the mouth with the intention of inserting an endotracheal tube (ETT), regardless of whether an ETT was inserted. Laryngoscopy time is the time from insertion of the laryngoscope blade into the mouth during an intubation attempt until removal of the blade, regardless of whether an ETT was successfully inserted. Total laryngoscopy time is defined as the cumulative duration of laryngoscopy time of all intubation attempts undertaken until ETT is inserted and confirmed by exhaled carbon dioxide detection or the procedure is abandoned.

次要结局

  • Lowest heart rate during attempt(24 months)
  • Number of intubation attempts(24 months)
  • Duration of each attempt(24 months)
  • Lowest oxygen saturation during attempt(24 months)
  • Chest compressions during procedure(24 months)
  • Adrenaline administration during procedure(24 months)
  • Oral trauma(24 months)
  • Crossover to alternative operator(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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