Videolaryngoscope vs Classic Laryngoscope in Teaching Neonatal Endotracheal Intubation: a Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- Endotracheal intubation success rate.
研究概览
简要总结
Every year thousands of neonates born in North America need extensive resuscitation which often includes endotracheal intubation (ETI). In these situations, Pediatricians assume the role of Neonatal Resuscitation Program (NRP) providers and are responsible of the ETI procedure. They acquire this skill during residency training in the Neonatal Intensive Care Unit (NICU) and the delivery room. Difficulties in performing neonatal ETI lie in the small size of the mouth and airway of the neonate, and their particular anatomy of the larynx. This limited visibility represents a challenge even for the experienced clinician. Recently, a new videolaryngoscope (VL) technique has been introduced to the adult and pediatric medical fields as described respectively by Kaplan et al. and Weiss et al. In 2009, Vanderhal et al. reported a preliminary experience in the newborn population. Video assisted intubation could be a method of choice in teaching neonatal ETI.
To the best of our knowledge, there is no human study comparing the VL to the classic laryngoscope (CL) for acquiring the skill of neonatal ETI in the NICU.
This study aims:
- To assess if the videolaryngoscope is superior to the classic laryngoscope in acquiring the neonatal endotracheal intubation skill in the Neonatal Intensive Care Unit; and
- To assess if once the skill is acquired with the videolaryngoscope this experience is transferable to the use of the classic laryngoscope by showing a persistent difference in success rate in favor of the videolaryngoscope group.
The hypothesis are
- Primary hypothesis:
In the Neonatal Intensive Care Unit, use of the videolaryngoscope will increase success rate of endotracheal intubation by 20% compared to the classic laryngoscope. Later, acquired experience from the videolaryngoscope will be transferable to the use of the classic laryngoscope by showing a persistent difference in success rate of 20% in favor of the videolaryngoscope group. 2. Secondary hypothesis We expect that the videolaryngoscope will decrease time to intubation, and decrease rate of esophageal and right bronchial main stem intubations. It will also improve teaching of endotracheal intubations to pediatric residents by helping supervisors recognize problems related to intubation and by improving residents' level of confidence in performing the skill.
详细描述
Methodology
Consent to the study
The principal investigator will approach all pediatric residents to participate in the study. Parents of children will be approached by the principal investigator or the clinical research coordinator either antenatal or on admission to the NICU in the case of an eventual need for the infant of ETI. If the consent is made antenatally, we will insure that it is done by a different physician than the one performing the antenatal consultation.
Training to ETI
In our centre, residents learn neonatal ETI in the simulation centre at CHU Ste-Justine as first year residents when they are taught the NRP at the end of June every year, one week before starting residency training. The procedure is explained and demonstrated on a mannequin (Laerdal Neonatal Intubation Trainer) using the CL by a neonatologist and then residents practice on the same mannequin a couple of times (3-5). Further training is done in the clinical setting on real patients in an opportunistic manner. In both situations, they are supervised by a neonatologist or a senior subspecialty resident who will guide, coach and give them constructive feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Trainees: All residents registered in the three first years of the general pediatrics program of University of Montreal will be approached to participate in the study.
- •Patients: All ETI attempted by pediatric residents in the NICU will be included in the study regardless of the patient weight or gestational age.
排除标准
- •Trainees: Residents who perform less than five neonatal ETI per method.
- •Patients: patients with major oral, cervical or upper airway malformations, urgent ETI with the inability to prepare in time the VL, and an unexpected difficult ETI.
研究组 & 干预措施
Classic laryngoscope
Phase 1 and 2: Endotracheal intubation using the classic laryngoscope with Miller blade 0 or 1 according to weight of infant.
干预措施: Miller laryngoscope (Device)
Videolaryngoscope
Phase 1: Endotracheal intubation using the videolaryngoscope with blade 0 or 1 according to weight of infant. videolaryngoscope will be used to proceed to endotracheal intubation indirectly with the use of the video monitor for guidance. Phase 2: Endotracheal intubation using the classic laryngoscope with Miller blade 0 or 1 according to weight of infant.
干预措施: Storz videolaryngoscope (Device)
结局指标
主要结局
Endotracheal intubation success rate.
时间窗: 5 minutes
次要结局
- Rate of esophageal and right bronchial main stem intubations.(15 minutes)
- Supervisor's ease in recognizing problems with endotracheal intubation.(15 minutes)
- Time to intubation.(5 minutes)
- Resident's level of confidence in attempting endotracheal intubation.(15 minutes)
研究者
Ahmed Moussa
Dr Ahmed Moussa
St. Justine's Hospital