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临床试验/CTRI/2025/09/094156
CTRI/2025/09/094156尚未招募3 期

Early vs Conventional High-Frequency Oscillatory Ventilation in Moderate and Severe Acute Respiratory Distress syndrome: An Open Labelled Randomized Superiority Controlled Trial

Division of Pediatric Critical Care Department of Pediatrics AIIMS Raipur1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月16日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To compare 28-day mortality outcomes between

研究概览

简要总结

Physiologically High Frequency Oscillatory Ventilation is better than Conventional Mechanical Ventilation as constant distending pressure with low tidal volume delivery reduces Ventilator-induced lung Injury. However, this didn’t translate into clinical practice as per studies done in adults. In the pediatric population, though HFOV is used as a rescue modality of ventilation, prospective studies to see the benefit of early HFOV versus conventional ventilation followed by rescue HFOV are lacking. Most of the evidence is from post hoc secondary analysis or retrospective analysis and patient selection too isn’t uniform across studies: Few of them have just considered post-marrow transplant recipients, and few of them have included patients with diagnoses other than severe ARDS. So, we propose to investigate the benefits of early HFOV over rescue HFOV usage in case of moderate and severe ARDS defined as per PALICC 1 guidelines by doing a randomized controlled trial in our setting.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Month(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • Children aged 1 month to 14 years admitted in PICU, with moderate and severe ARDS classified as per PALICC 1 guidelines.

排除标准

  • History of interstitial lung disease
  • Chronic renal failure
  • Central nervous system involvement: Especially raised intracranial pressure
  • Immunodeficient patients including malignancy and post marrow transplant recipients
  • Post cardiac surgery patients
  • Consent denial.

结局指标

主要结局

To compare 28-day mortality outcomes between

时间窗: To compare 28-day mortality outcomes between | early HFOV group and conventional/ rescue HFOV group.

early HFOV group and conventional/ rescue HFOV group.

时间窗: To compare 28-day mortality outcomes between | early HFOV group and conventional/ rescue HFOV group.

次要结局

  • To determine the time taken for improvement in oxygenation and ventilatory parameters,(duration of ventilation and length of ICU stay.)

研究者

发起方
Division of Pediatric Critical Care Department of Pediatrics AIIMS Raipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sathwik Gangireddy

All India Institute of Medical Sciences, Raipur

研究点 (1)

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