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临床试验/NCT02085499
NCT02085499已完成不适用

Effects of Flow-synchronized Nasal Intermittent Mandatory Ventilation in Preterm Infants

University of Miami2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Ttidal volume (VT)

研究概览

简要总结

The use of non-invasive methods of respiratory support to reduce complications of prolonged invasive mechanical ventilation in preterm infants has increased.

The most common mode is nasal intermittent mandatory ventilation (NIMV). In NIMV, the interval between mechanical breaths is fixed and is determined by the frequency dialed by the clinician. Asynchrony between the infant's spontaneous breathing may exist since mechanical breaths delivered at fixed intervals can occur at different times over the inspiratory or expiratory phases of the infant's spontaneous breathing. Synchronized-NIMV is a mode similar to NIMV where the ventilator cycle is delivered in synchrony with the infant's spontaneous inspiration. This has been achieved by using techniques to detect the infant's spontaneous inspiration.

The advantages or disadvantages of synchronized compared to non-synchronized NIMV remain to be determined.

This study seeks to evaluate the effect of synchronized NIMV versus non-synchronized NIMV on ventilation and gas exchange in premature infants who require supplemental oxygen.

The hypothesis is that the use of flow synchronized nasal intermittent mandatory ventilation (S-NIMV) in comparison to non-synchronized NIMV will improve ventilation and gas exchange and reduce breathing effort.

The objective of the study is to compare the effect of flow synchronized-NIMV to non-synchronized-NIMV on tidal volume (VT), minute ventilation (VE), gas exchange, breathing effort, apnea and chest wall distortion in preterm neonates with lung disease.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Preterm infants of 30 or less weeks of gestational age
  • Receiving NIMV
  • Requiring Fi02 > 0.21 to keep Sp02 > 90%
  • Parental written informed consent

排除标准

  • Major congenital anomalies
  • Proven sepsis within 72 hours of the study
  • Hypotension requiring pressors within 72 hours of the study
  • Pneumothorax or pneumomediastinum within 72 hours of the study
  • Current suspected necrotizing enterocolitis, spontaneous perforation or severe abdominal distention

结局指标

主要结局

Ttidal volume (VT)

时间窗: 4 hours

Measurements of tidal volume (VT in ml-units/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV

Minute Ventilation

时间窗: 4 hours

Measurements of minute ventilation (VE in ml-units/min/Kg) by respiratory inductance plethysmography during flow synchronized-NIMV will be compared to measurements during non-synchronized-NIMV

次要结局

  • Arterial oxygen saturation(4 hours)
  • fraction of inspired oxygen(4 hours)
  • transcutaneous carbon dioxide tension(4 hours)

研究者

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

Nelson Claure

Research Associate Professor

University of Miami

研究点 (2)

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