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临床试验/CTRI/2025/03/081596
CTRI/2025/03/081596尚未招募不适用

Role of lung ultrasound in predicting extubation success in mechanically ventilated neonates

Himalayan Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年3月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
62
试验地点
1
主要终点
To evaluate predictive ability of lung ultrasound for extubation success.

研究概览

简要总结

Both inborn and outborn neonates fulfilling inclusion criteria will ne enrolled. Initially in pre- initiation training, a senior resident will be trained by consultant neonatologist for 1 month. To decrease inter observer variability when k > 0.8, study will be initiated. Subjects will be enrolled 2 hours before extubation. Demographics and perinatal details will be collected. Babies admitted to NICU will be followed prospectively and details of management will be recorded like whether received  surfactant or  not indication of ventilation, mode and  duration of ventilation, settings of ventilator, maximum ventilation index during ventilation,  maximum respiratory severity score (RSS) during ventilation. Lung USG score will be done within 2 hours before extubation. Baby can be extubated if FiO2 requirement < 40 %,   MAP < 8- 10cm H2O,  Respiratory rate of the ventilator < 30/min,   presence of spontaneous breathing,  haemodynamically stable without or with 1 ionotrope, last haemoglobin>10 mg/dl , no metabolic acidosis (pH>7.2)  with PaCO2- < 55mmHg, PaO2>40 mmHg  in arterial blood gas (ABG) done 2 hours before extubation or based on clinical judgement of consultant neonatologist. Post extubation neonate will be shifted to non invasive mode of ventilation (NIV). Lung ultrasound score of those who failed the first extubation attempt and those who were successful will be compared to develop final cut off score for extubation success.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • All consecutive neonates on conventional ventilation for at least 24 hours.

排除标准

  • Previous extubation failures Accidental extubation Life threatening congenital malformations Upper airway malformations Surgical cases(Tracheo-esophageal fistula, congenital diaphragmatic hernia, intestinal atresia, necrotising enterocolitis) requiring intubation Neonates with critical congenital heart disease Chest deformities.

结局指标

主要结局

To evaluate predictive ability of lung ultrasound for extubation success.

时间窗: till 3 days post extubation

Word outcome refers to no need of re-intubation within 3 days after extubation(successful extubation)

时间窗: till 3 days post extubation

次要结局

  • 1.To develop cut off lung ultrasound score with highest area under curve (AUC)for extubation success.(2.To compare predictive ability of lung ultrasound score on screening 6 versus 12 areas for extubation success.)

研究者

申办方类型
Private medical college

研究点 (1)

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