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临床试验/CTRI/2025/01/079264
CTRI/2025/01/079264尚未招募不适用

A prospective observational study to determine the ultrasonographic assessment of diaphragm function as a predictor of extubation success in ventilated neonates in the NICU

Bharati Vidyapeeth Deemed University Medical College Pune1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年11月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To determine the ultrasonographic assessment of diaphragm function as a predictor of extubation success in ventilated neonates in the NICU

研究概览

简要总结

We hypothesize that assessment of diaphragmatic dimensions and excursion, before planned extubation in neonates, may be helpful in predicting successful extubation of infants from mechanical ventilation. We further hypothesize that a combination of diaphragmatic function assessment, in association with lung sonography and the ratio of Oxygen Saturation to fraction of inspired Oxygen (SpO2:FiO2) would be a good predictor to success of extubation.  We aim to evaluate the diaphragmatic dimensions and excursion in ventilated neonates prior to extubation, and create a prediction model for extubation success, based on diaphragm function, lung score and SF ratio as a predictor for success of extubation

研究设计

研究类型
Observational

入排标准

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

入选标准

  • All neonates admitted to NICU requiring mechanical ventilation for at least 48 hours of life, and planned for extubation as determined by the clinical team.

排除标准

  • Major life- threatening congenital malformations, major chromosomal anomalies
  • Major congenital heart diseases or lung disorders
  • Congenital anomalies related to the diaphragm as diaphragmatic hernias, and diaphragmatic paralysis
  • Pleural effusion or Pneumothorax with or without an intercostal drain in situ
  • Neonatal encephalopathy.

结局指标

主要结局

To determine the ultrasonographic assessment of diaphragm function as a predictor of extubation success in ventilated neonates in the NICU

时间窗: 48 hours

次要结局

  • 1. To compare the predictive accuracy of ultrasonographic assessment of diaphragm function and ultrasound assessment of the lung (lung score) for successful extubation

研究者

发起方
Bharati Vidyapeeth Deemed University Medical College Pune
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Anurag Sanjeev Pikle

Bharati Vidyapeeth, Pune

研究点 (1)

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