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临床试验/CTRI/2025/08/092591
CTRI/2025/08/092591尚未招募不适用

Ventilator Induced Diaphragmatic dysfunction in critically ill mechanically ventilated children

Maulana Azad Medical college1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
The proportion of patient with Ventilator Induced diaphragmatic dysfunction in Mechanically ventilated patient

研究概览

简要总结

Mechanical ventilation is a life saving intervention which aims at exchange of gases totally or partially compensating for the lung. However it is associated with Diaphragmatic muscle injury (myotrauma) leading to diaphragmatic dysfunction.

The incidence of ventilator associated diaphragmatic dysfunction helps in identifying the percentage of intubated children prone to develop diaphragmatic dysfunction. There is  no single specific cause for ventilator associated diaphragmatic dysfunction, multiple factors and multiple pathophysiology are proposed for its cause. The ventilator induced diaphragmatic dysfunction(VIDD) plays an important role in modifying the outcome of the patient in the extubation trials and the course of stay in intensive care unit. The ultrasound guided assessment of diaphragmatic function is a useful bedside point of care tool , that can be used to identify  patients with ventilator associated diaphragmatic dysfunction, and has shown good accuracy and reproducibility.It gives an additional advantage of non invasive assessment of diaphragmatic function.

Through this study we shall prospectively assess diaphragmatic dysfunction serially in intubated children. Concomitantly we shall assess parameters which may lead to causation of VIDD as muscle wasting (through quadriceps femoris muscle thickness), presence of shock (mean VIP), ischemia (mean OI/OSI), nutrition and ventilation (ventilation settings).

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 1.Children between 1 month to 12 years requiring mechanical ventilation 2.Mechanical ventilation for more than 24 hours 3.Admission to Pediatric intensive care unit or Pediatric High dependency unit in department of Pediatrics, MAMC and associated LN Hospital.

排除标准

  • 1.Children with known diagnosis of Myasthenia Gravis, Guillian barre syndrome, Amyotropic lateral sclerosis, Cervical spinal cord injury, and Spinal muscular atrophy, bronchopleural fistula.
  • 2.Children those who were ventilated for more than 24 hours prior to presentation into Intensive care unit.

结局指标

主要结局

The proportion of patient with Ventilator Induced diaphragmatic dysfunction in Mechanically ventilated patient

时间窗: 2 week

次要结局

  • 1.Factors associated with causation of Ventilator induced diaphragm dysfunction including muscle wasting (as assessed by QFMT, skin fold thickness), inotrope requirement (as assessed by mean vasoactive inotropic score), oxygen requirement (as assessed by mean oxygenation index ), calorie intake, presence of AKI, delay in starting feeds, drug associated sarcopenia, dyselectrolytemia, ventilation parameters etc.(2 week)
  • 2. Association of Ventilator induced diaphragmatic dysfunction with clinical outcomes such as mortality, duration of stay, duration of ventilation etc.(2 week)
  • 3. Diaphragmatic thickness fraction ratio as a predictor of success of spontaneous breathing trial and extubation success.(2 week)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Naavendan R

Maulana Azad Medical College

研究点 (1)

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