跳至主要内容
临床试验/NCT03649282
NCT03649282已完成不适用

Comparisons of the Dynamic of the Cardiorespiratory System Behavior of Extreme Preterm Infants Receiving Nasal CPAP or High Flow Nasal Cannula During the Immediate Post-extubation Period

Guilherme Sant'Anna, MD2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Differences on Heart Rate Variability in extremely preterm infants receiving HFNC and NCPAP

研究概览

简要总结

To avoid or decrease the rate of complications in preterm infants after disconnection from a mechanical ventilation (extubation), non-invasive respiratory support is routinely used. While infants are most commonly extubated to nasal continuous positive airway pressure (NCPAP), high flow nasal cannula (HFNC) has emerged as an attractive alternative. However, research regarding the safety and efficacy of HFNC in the most extreme preterm infants is limited. Therefore, we hypothesize that immediately after extubation, measures of heart rate and respiratory behavior may be useful to investigate for any differences between HFNC and NCPAP.

详细描述

Infants will be studied 30 min after extubation on both modes of support, provided in a random order. A transition period of 15 min between modes will be given. For each mode, recordings will be performed for 40 minutes. Analysis of these recordings will be done off line.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Infants with birth weight ≤ 1250 grams
  • Infants that have been mechanically ventilated and undergoing their first elective extubation attempt

排除标准

  • Major congenital anomalies, neuromuscular disease, hemodynamic instability (use of vasopressors or hypotension).
  • Infants reintubated before initiation or during data collection.
  • Parental/legal guardian consent not obtained.

结局指标

主要结局

Differences on Heart Rate Variability in extremely preterm infants receiving HFNC and NCPAP

时间窗: Immediate post-extubation period

Cardiac signals from the electrocardiogram will be continuously measured throughout the recordings. Analysis of these signals will be performed offline to calculate heart rate variability using linear and nonlinear methods.

Differences on Respiratory Variability in extremely preterm infants receiving HFNC and NCPAP

时间窗: Immediate post-extubation period

Respiratory variability will be calculated by using analysis of respiratory inductive pletysmography signals from the recordings during HFNC and NCPAP. Desaturation events will also be calculated from these recordings.

次要结局

未报告次要终点

研究者

发起方
Guilherme Sant'Anna, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Guilherme Sant'Anna, MD

Associate Professor, Department of Paediatrics, McGill University Health Center

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

Loading locations...

相似试验