跳至主要内容
临床试验/NCT04258722
NCT04258722已完成不适用

Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2020年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
No flow fraction

研究概览

简要总结

Teleneonatology, the use of audio-video communication to facilitate neonatal-perinatal care, may bridge the resuscitation quality gap by connecting centers with lower level care to experienced care providers. Using randomized trial design, this investigation will compare teleneonatal resuscitation facilitated by a neonatologist to standard resuscitation within a simulated environment.

详细描述

Multiple studies have evaluated telemedicine using simulation, but the level of evidence for the use of telemedicine to improve neonatal resuscitation is low.

In this investigation and within a simulated environment, pediatric interns and residents will resuscitate a simulated 25 week infant at delivery assisted by a simulated nurse and respiratory therapist. Participants will be randomized to resuscitation performed either with or without telemedicine facilitated by a neonatologist. The primary outcome will be time to effective ventilation with other secondary outcomes including metrics derived from the American Academy of Pediatrics Neonatal Resuscitation Program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors will be masked to group allocation.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for experienced providers include at least 3 years of pediatric and/or neonatal training, having previously performed >10 endotracheal intubations, and may include neonatologists, pediatric fellows, and neonatal nurse practitioners. Inclusion criteria for trainees: previous exposure to NRP, an interval of > 3 months elapsing between previous NRP applications, and may include pediatric residents, family medicine residents, nurses, respiratory therapists, neonatal fellows, and neonatal attendings.

排除标准

  • Does not meet inclusion criteria

结局指标

主要结局

No flow fraction

时间窗: From start time of compression until 60 seconds have elapsed

The proportion of time for which the mannequin received no effective compression (the number of seconds without effective chest compressions divided by the total number of seconds)

次要结局

  • Compression rate per minute(From start time of compression until 10 seconds have elapsed)
  • Temperature regulation(From baseline to 30 seconds)
  • Time of first heart rate check (seconds)(From baseline until heart rate check up to 5 minutes)
  • Sat probe placement compliance(From baseline to 60 seconds)
  • MR SOPA Performance: Increased pressure(From start of bag mask ventilation to 2 minutes)
  • Heart rate check compliance(From baseline to 60 seconds up to 5 minutes)
  • Time of sat probe placement (seconds)(From baseline to probe placement up to 5 minutes)
  • Time of bag mask ventilation (seconds)(From baseline to bag mask placement up to 5 minutes)
  • Bag mask ventilation compliance(From baseline to 60 seconds)
  • MR SOPA Performance: Suction mouth(From start of bag mask ventilation to 2 minutes)
  • MR SOPA Performance: Placed advanced airway(From start of bag mask ventilation to 2 minutes)
  • Number of steps correctly performed(From start of bag mask ventilation to 2 minutes)
  • No blow fraction(From baseline to 10 minutes)
  • Time of increase in FiO2 (seconds)(From simulation start to time of FiO2 increase up to 5 minutes)
  • MR SOPA Performance: Mask adjustment(From start of bag mask ventilation to 2 minutes)
  • MR SOPA Performance: Reposition airway(From start of bag mask ventilation to 2 minutes)
  • MR SOPA Performance: Open mouth(From start of bag mask ventilation to 2 minutes)
  • Time to effective ventilation (seconds)(From baseline to time of first ventilated breath with an endotracheal tube up to 10 minutes)
  • Time to first compression (seconds)(From baseline until first compression up to 5 minutes)
  • Correct hand position(From baseline until first compression up to 5 minutes)
  • Compression depth compliance(From baseline until first compression up to 5 minutes)
  • MR SOPA performed in correct sequence(From start of bag mask ventilation to 2 minutes)
  • MR SOPA measures all performed(From start of bag mask ventilation to 2 minutes)
  • Compression synchronization compliance(From start time of compression until 60 seconds have elapsed)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samuel Gentle

Assistant Professor

University of Alabama at Birmingham

研究点 (2)

Loading locations...

相似试验