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临床试验/NCT01909947
NCT01909947已完成不适用

Prediction of Extubation Readiness in Extreme Preterm Infants by the Automated Analysis of CardioRespiratory Behavior: the APEX Study

McGill University Health Centre/Research Institute of the McGill University Health Centre5 个研究点 分布在 2 个国家目标入组 266 人开始时间: 2013年9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
266
试验地点
5
主要终点
Extubation Failure

研究概览

简要总结

The investigators hypothesize that machine learning methods using a combination of novel, quantitative measures of cardio-respiratory variability can accurately predict the optimal time to extubate extreme preterm infants. In this multicenter prospective study, cardiorespiratory signals will be recorded from 250 extreme preterm infants who are eligible for extubation. Automated signal analysis algorithms will compute a variety of metrics for each infant describing the cardiorespiratory state. Machine learning methods will then be used to find the optimal combination of these statistical measures and clinical features that provide the best overall predictor of extubation readiness. Finally, investigators will develop an Automated system for Prediction of EXtubation (APEX) that will integrate the software for data acquisition, signal analysis, and outcome prediction into a single application suitable for use by medical personnel in the Neonatal Intensive Care Unit (NICU). The performance of APEX will later be clinically validated in 50 additional infants prospectively.

详细描述

At birth, extreme preterm infants (≤28 weeks) have inconsistent respiratory drive, airway instability, surfactant deficiency and immature lungs that frequently result in respiratory failure. Management of these infants is difficult and most will require endotracheal intubation and mechanical ventilation (ETT-MV) within the first days of life to survive. ETT-MV is an invasive therapy that is associated with adverse clinical outcomes including ventilator-associated pneumonia, impaired neurodevelopment, and increased mortality. Consequently, clinicians try to remove ETT-MV as quickly as possible. However, 25 to 35% of these extubation attempts will fail and infants will require reintubation, an intervention that is also associated with increased morbidity and mortality. Therefore physicians must determine the optimal time for extubation which minimizes the duration of ETT-MV and maximizes the chances of success. A variety of objective measures have been proposed to assist with this decision but none has proven to be useful clinically. Investigators from this group have recently explored the predictive power of indices of autonomic nervous system function based on measurements of heart rate (HRV) and respiratory variability (RV). The use of sophisticated, automated algorithms to analyze those cardiorespiratory signals have shown some promising preliminary results in predicting which infants can be extubated successfully.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All infants admitted to the NICU with a birth weight ≤ 1250 grams AND
  • Need for endotracheal tube mechanical ventilation

排除标准

  • Infants with major congenital anomalies
  • Infants with congenital heart disease and cardiac arrhythmias
  • Infants receiving vasopressor or sedative drugs at the time of extubation
  • Infants extubated directly from high frequency ventilation
  • Infants extubated to room air, oxyhood or low-flow nasal cannula

结局指标

主要结局

Extubation Failure

时间窗: Within 72 hours of extubation

Infants will be considered to have failed extubation if they meet one or more of the following criteria within 72 hours of extubation: 1. Fraction of inspired oxygen (FiO2) \> 0.5 in order to maintain oxygen saturation (SpO2) \> 88% or PaO2 \> 45 mmHg (for 2 consecutive hours) 2. PaCO2 \> 55-60 mmHg with a pH \< 7.25 in two consecutive blood gases done 1-2 hours apart 3. 1 episode of apnea requiring positive pressure ventilation with bag and mask 4. Multiple episodes of apnea (≥ 6 episodes / 6 hours).

次要结局

  • The need for reintubation(Anytime from the first planned extubation until discharge from the neonatal intensive care unit)
  • The need for reintubation within 72h of the first planned extubation(Within 72 hours of extubation)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guilherme Sant'Anna, MD

Associate Professor of Pediatrics

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

研究点 (5)

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