跳至主要内容
临床试验/NCT03694379
NCT03694379终止不适用

Randomized Controlled Trial of Apneic Oxygenation Including Precipitous Intubations During RSI in the Emergency Department

Rutgers, The State University of New Jersey2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
2
主要终点
Lowest oxygen saturation overall

研究概览

简要总结

This RCT is testing the efficacy of apneic oxygenation during endotracheal intubation in the emergency department. Currently the standard practice in the ED when performing endotracheal intubation is that some providers use apneic oxygenation (the application of a nasal cannula at 15LPM) throughout the intubation procedure, while others do not apply apneic oxygenation. Initial literature in the operating room showed that apneic oxygenation helps prevent desaturation during the procedure. However, the latest literature conducted in critical care settings (one study in the ICU and one in the ED) questions the efficacy of this intervention in critically ill patients; however, no harm has been shown. Our study aims to test this intervention further by adding in a special subset of patients that was excluded from prior studies, precipitous intubations, or those patients that have to be intubated quickly and cannot have adequate pre-oxygenation. We hypothesize that apneic oxygenation will be more efficacious in this subset than in the overall ED population. We will randomize patients requiring endotracheal intubation into intervention (apneic oxygenation) and control (no apneic oxygenation). We will measure the lowest arterial oxygen saturation from the start of the intubation procedure through 2 minutes after intubation is complete.

研究设计

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

入排标准

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

入选标准

  • The inclusion criteria for our study will include patients 18 years or older who require emergent endotracheal intubation utilizing rapid sequence intubation (RSI) in the Emergency Department with first attempt taken by a resident or attending physician working in the emergency department. This includes Emergency Medicine attending physicians and residents as well as non-Emergency Medicine rotators (e.g.., Internal Medicine residents who are rotating through the Emergency Department).

排除标准

  • Exclusion criteria include patients who are in cardiac arrest, or if the patient received any positive pressure ventilation (i.e, BPAP, CPAP, BVM) in the emergency department before RSI.

结局指标

主要结局

Lowest oxygen saturation overall

时间窗: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation

Lowest oxygen saturation between overall control and intervention groups

次要结局

  • Difference in baseline and final oxygen saturation(Decision to intubate through 2 minutes after completion of endotracheal intubation)
  • Desaturation(Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation)
  • Hospital length of stay(Up to 28 days after intubation)
  • Number of days intubated(Up to 28 days after intubation)
  • Lowest oxygen saturation precipitous intubations(Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation)
  • Need for second operator(From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.)
  • In-hospital mortality(Up to 28 days after intubation)
  • Difference in oxygen saturation before and after apneic period(Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation)
  • Procedural hypotension(Initiation of neuromuscular blockade to 2 minutes after completion of endotracheal intubation)
  • Need for additional intubating equipment(From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.)
  • Aspiration(Within 24 hours after intubation procedure was complete)
  • Lowest oxygen saturation pre-oxygenation(Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation)
  • number of attempts(From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.)
  • Esophageal intubations(From first attempt at intubation through entire ED stay, approximately 6 hours.)

研究者

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

Ilya Ostrovsky, MD

Assistant Professor of Emergency Medicine

Rutgers, The State University of New Jersey

研究点 (2)

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