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临床试验/NCT03265548
NCT03265548已完成不适用

Comparison Between Direct Laryngoscopy and Video Laryngoscopy for Neonatal Intubation. Confidence of Staff and Number of Attempts to Successful Intubation

Royal Devon and Exeter NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2016年6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
已完成
发起方
入组人数
39
试验地点
2
主要终点
Number of attempts to successful intubation

研究概览

简要总结

Our research questions are

  1. Will the use of a video laryngoscope lead to decreased attempts
  2. Does this result in more successful intubations and greater confidence in the supervisor and the team that a successful intubation has been performed.

详细描述

Neonatal intubation is a technically difficult, but essential, skill to learn, involving passing a plastic tube through the vocal cords, into the trachea. Current practice involves using a laryngoscope to directly visualise the cords, however this technique does not allow the supervisor to witness the tube passing through the cords. Video laryngoscopes have a camera at the distal end of the blade, allowing an 85% viewing angle as opposed to 15% that is seen with direct view. In addition, the image is projected onto a screen, allowing all members of the team to visualise the intubation and therefore provide real time guidance as well as increased confidence in the outcome of the attempt. Video laryngoscopes are used in neonates in other specialities, for example Ear Nose and throat or respiratory physicians, and are becoming routinely used by neonatologists. The research questions are whether using a video laryngoscope will lead to decreased attempts, which in turn will potentially result in more successful intubations and greater confidence in the supervisor and the team that a successful intubation has been performed.

The aim is to recruit 40 babies and randomly allocate the participant to either direct laryngoscopy or video laryngoscopy for elective intubations. Number of attempts to successful intubation would be recorded, in addition to confidence of supervisor and the team regarding the outcome of the attempt.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Device Feasibility
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Any baby requiring intubation on a neonatal unit

排除标准

  • Infants will not be recruited if they are in extremis requiring immediate intubation by a senior experienced operator who will use his/her own preferred method. Infants who will be intubated nasally will not be included as this technique is not usually taught to registrars.
  • Any baby with a congenital airway malformation will not be included in the study

研究组 & 干预措施

Standard

No Intervention

Usual Direct view laryngoscopy

Intervention

Experimental

Video laryngoscopy

干预措施: Video Laryngoscope (Device)

结局指标

主要结局

Number of attempts to successful intubation

时间窗: Each attempt is defined by the need to stop the attempt and give non-invasive support. A maximum of 3 attempts per trainee. The eligible participant is any baby on NNU who requires intubation

How many attempts before successful intubation

Team confidence around tube placement at the time of tube placement

时间窗: immediately after the intubation

Continuous line to score the confidence of the individuals in the team

次要结局

未报告次要终点

研究者

发起方
Royal Devon and Exeter NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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