跳至主要内容
临床试验/NCT01381068
NCT01381068已完成不适用

Quantitative End Tidal CO2 Monitoring in the Delivery Room: Can we Prevent Hypo/Hypercapnia Upon Admission to the NICU?

Neil Finer2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
PCO2 Level Outside of Desired Range (40-60 mmHg)

研究概览

简要总结

This is a trial evaluating the use of an end tidal CO2 monitor during ventilation in the delivery room. The use of the monitor is compared with clinical assessment of ventilation. The hypothesis is that using the monitor would results in a decrease in the incidence of hypo- or hypercapnia on admission to the NICU.

研究设计

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

入排标准

年龄范围
— 至 15 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • Need for ventilation in the delivery room

排除标准

  • Tracheal suctioning for meconium
  • Congenital Diaphragmatic Hernia
  • Suspected hypoplasia of the lungs
  • Oligohydramnios <28 weeks gestation or AFI<5
  • Known or suspected airway anomaly
  • Mother not speaking English or Spanish
  • Refusal of consent

结局指标

主要结局

PCO2 Level Outside of Desired Range (40-60 mmHg)

时间窗: Admission to NICU, approximately 1 hour of life

This outcome will be obtained from the first available blood gas after admission to the NICU.

次要结局

  • Oxygen Use at 36 Weeks(Hospital course, approximately 2-3 months)
  • Duration of Ventilation(Duration of the hospital course, approximately 2-3 months)
  • Incidence of Pneumothorax/Airleak(Hospital course, approximately 2-3 months)
  • Number of Patients Ventilated on NICU Admission(On NICU admission, approximately 15 minutes of life)
  • Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow(Within 12 hours of life)
  • End Tidal CO2 Levels(At the conclusion of resuscitation, approximately 15 minutes of life.)

研究者

发起方
Neil Finer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Neil Finer

Professor Emeritus

University of California, San Diego

研究点 (2)

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