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临床试验/NCT07764575
NCT07764575尚未招募不适用

Predictors of Extubation Failure in Ventilated Neonates

Assiut University0 个研究点目标入组 124 人开始时间: 2026年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
124
主要终点
The role of functional echocardiography in predicting exutbation failure

研究概览

简要总结

This protocol proposes a prospective observational study to develop and validate such a model, directly addressing a critical evidence gap identified by recent systematic reviews.

详细描述

Mechanical ventilation (MV) is life-saving in the neonatal intensive care unit (NICU), yet extubation timing remains one of the most consequential and poorly standardized decisions in neonatology. The rate of extubation failure (EF) increases from 20% in infants born at 28-31 weeks gestational age to more than 60% in very preterm infants born at less than 28 weeks gestational age, for several reasons including frequent or severe apneas, residual lung disease, immature respiratory drive, and the presence of an unstable patent ductus arteriosus (PDA) .

EF is defined as the need for reintubation within 72 hours of a planned extubation attempt, and its consequences are profound. EF not only prolongs the duration of MV but is independently associated with increased mortality, morbidity, length of hospital stay, and healthcare costs.

Clinical judgment, personal experience, bedside observation of blood gases, oxygen requirements, and ventilator settings are typically used to make decisions on whenever to extubate or not. Consequently, there are significant practical differences and a paucity of protocols to simplify the management of all components of the peri-extubation process, with decisions often being physician-dependent rather than evidence-based, which may lead to inappropriate extubation.

The emergence of point-of-care ultrasound (POCUS) and targeted neonatal echocardiography (TNE) has created new opportunities for objective, real-time, bedside physiological assessment. Lung ultrasound score (LUS), diaphragmtic thickening fraction (DTF) and excursion, arterial blood gas (ABG) analysis, and functional echocardiographic hemodynamic assessment, including left ventricular outflow tract velocity time integral (LVOT VTI), right ventricular outflow tract (RVOT), and patent ductus arteriosus (PDA) characterization, represent four physiologically independent domains that together capture the full spectrum of mechanisms underlying extubation failure. No validated multimodal bedside scoring tool combining all four domains currently exists in neonatology.

This protocol proposes a prospective observational study to develop and validate such a model, directly addressing a critical evidence gap identified by recent systematic reviews.

研究设计

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

入排标准

年龄范围
1 Day 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Neonates (gestational age 28-44 weeks corrected) mechanically ventilated for ≥48 hours
  • Planned extubation as determined by the treating neonatologist
  • Hemodynamically stable at enrollment

排除标准

  • Major congenital anomalies
  • Neuromuscular disorders
  • Thoracic malformations
  • Inborn error of metabolism
  • Unplanned/accidental extubation

研究组 & 干预措施

Extubatuin sucess

Parameters of neonates who will be successed to be weaned

Extubation failure

Parameters of neonates who will be failed to be weaned

结局指标

主要结局

The role of functional echocardiography in predicting exutbation failure

时间窗: baseline

The role of functional echocardiography in predicting exutbation failure

The role of Chest ultrasound in predicting extubation failure

时间窗: baseline

The role of Chest ultrasound in predicting extubation failure

The role of plasma soluble intercellular adhesion molecule-1 in predicting extubation failure

时间窗: baseline

The role of plasma soluble intercellular adhesion molecule-1 in predicting extubation failure

次要结局

未报告次要终点

研究者

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

Nahla Sameh Abd El-Aleem Mahmoud

Assistant Lecturer

Assiut University

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