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临床试验/NCT03194503
NCT03194503已完成不适用

Improving Safety and Quality of Tracheal Intubations in Neonatal ICUs

Children's Hospital of Philadelphia14 个研究点 分布在 3 个国家目标入组 1,512 人开始时间: 2018年1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
入组人数
1,512
试验地点
14
主要终点
Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years

研究概览

简要总结

The purpose of the study is to determine the efficacy of video coaching training for neonatology attending providers on tracheal intubation procedural outcomes in neonatal ICUs.

详细描述

Tracheal intubation (TI) is the most common life-saving intervention for resuscitation and stabilization of critically ill neonates in Neonatal Intensive Care Units (NICUs).Recently, video laryngoscopy (VL) has become available in neonatal clinical practice to allows trainees and frontline providers to perform standard direct airway visualization (i.e., traditional laryngoscopy) while the supervisor can simultaneously view a real-time video displaying what the laryngoscopist is seeing. However, VL associated coaching during TI has not been rigorously evaluated.The purpose of the study is to determine the efficacy of video coaching training for neonatology attending providers on tracheal intubation procedural outcomes in neonatal ICUs. The primary objective of this study is to determine whether the video coaching skill training for neonatology attendings reduces the occurrence of adverse tracheal intubation associated events among all tracheal intubations in neonatal ICUs over 2 years before and after intervention. The secondary objectives are to 1) determine if video coaching training is feasible to all neonatology attending physicians using train the trainer approach with a remote simulation and 2) determine if the video coaching skill competency among neonatology attending physicians who completed the training using a remote simulation

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
22 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • VL coach: Neonatology attending physician position at each neonatal ICU, or Senior trainees who are anticipated to graduate within next 6 months to become neonatology attending physicians.
  • VL coach receivers: Trainees (medical students, residents, fellows except those graduating within next 6 months) and frontline providers (nurse practitioners, hospitalists, physician assistants, respiratory therapists, others who perform tracheal intubations under attending physicians' supervision)

排除标准

  • 未提供

研究组 & 干预措施

Trainees

No Intervention

Trainees will be coached as usual by attendings during their supervised intubation events

Attendings

Active Comparator

Study intervention is a VL coaching training for site neonatology attendings. Each site leader/key educator will be trained remotely by expert co-investigators. Site leaders and key educators will train their attendings. The quality of VL coaching skills will be verified by randomly auditing 20% of attending providers at each site for their skill assessment by remote simulation during the transition/post-intervention phase.

干预措施: VL Coaching training using C-MAC video laryngoscope (Device)

结局指标

主要结局

Number of Participants With Tracheal Intubation Associated Events (TIAEs) in the NICU Over 2 Years

时间窗: 2 years

Reduction in the occurrence of adverse tracheal intubation associated events among all tracheal intubations in neonatal ICUs over 2 years after neonatology attendings receive video coaching skill training.

次要结局

  • Number of Participants With Severe Oxygen Desaturation (>20% Decline in SpO2) Among Those With VL Coaching and Without VL Coaching(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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