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临床试验/NCT03374046
NCT03374046已完成不适用

Apneic Oxygenation in the Pediatric Intensive Care Unit

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2017年12月23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
41
试验地点
2
主要终点
Time to desaturation

研究概览

简要总结

The purpose of the study is to determine the impact of apneic oxygenation on the time to desaturation in pediatric patients treated in a pediatric intensive care unit (PICU). The investigators hypothesize pediatric patients will have an increase in time to desaturation with apneic oxygenation when compared to standard practice in the PICU.

详细描述

Oxygen (O2) desaturation is one of the risks of intubation, especially in critically ill children with comorbidities, increased O2 consumption and decreased O2 delivery. Desaturation places patients at greater risk for dysrhythmia, hemodynamic instability, hypoxic brain injury, and death. As shown in the oxyhemoglobin dissociation curve, once oxyhemoglobin (PaO2) saturations drop to ~ 90%, there is an increased risk for precipitous desaturation.

Although many may believe there would be no gas exchange during apnea, alveoli continue to take up oxygen even without diaphragmatic movements or lung expansion. As such, the administration of oxygen during intubation (when a patient is apneic) has not been a standard practice until recently.

Recent studies in adults have shown an increase in the time to desaturation when they are given concurrent oxygen administration during an intubation attempt. This use of oxygen during intubation is referred to as apneic oxygenation.

As a result of this work, apneic oxygenation has become standard practice in many emergency departments, even with pediatric patients. Yet, in pediatric hospital units, including intensive care, this is not the standard practice and no pediatric studies have been published on this subject to date.

In the study unit apneic oxygenation is not standard during intubation. The investigators would like to evaluate its use as it has shown benefits in prior research published on adults. Most patients in the PICU are already on a source of oxygen administration prior to intubation, this source of oxygen is usually removed during the intubation attempt, when the patient is apneic and not breathing on his/her own.

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
None

入排标准

年龄范围
0 Days 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Treated in the PICU at ACH-PR
  • Age 0 through17 years
  • Indication for emergent intubation
  • Premedication with a paralytic agent resulting in apnea

排除标准

  • No paralytic agent used
  • Elective intubations
  • Presence of cyanotic heart disease
  • Inability to safely place nasal cannula on patient
  • Nasal intubation
  • Patients already enrolled in the study (prior intubation)
  • Inability to randomize due to urgency of intubation
  • Females who are known to be pregnant

结局指标

主要结局

Time to desaturation

时间窗: Only during intubation

To evaluate the effect of apneic oxygenation in time to desaturation (\>/= 5% points from baseline O2 saturation) from the onset of apnea during intubation attempts in the PICU

次要结局

  • Number of Intubation Attempts(Only during intubation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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