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临床试验/CTRI/2024/02/062564
CTRI/2024/02/062564尚未招募2/3 期

Comparison of effects of post extubation non invasive ventilation with passive humidification and high flow nasal canula in patients with high risk of extubation failure

Era lucknow medical college and hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Reintubation within 48 hours of extubation

研究概览

简要总结

Post-extubation failure is defined as the need for reintubation within 48hrs of planned extubation.

Post extubation respiratory failure occurs in 10% to 20% of patients with planned extubation and results in reintubation

Re-intubation due to post-extubation failure is associated with poor outcomes which includes,

An increased incidence of ventilator-associated  pneumonia

Increased mortality rates

longer intensive care unit (ICU) and

hospital stays.

NIV is recommended in patients whom clinicians would normally consider NIV is beneficial (i.e. hypercapnic and obese patients)

A high flow nasal canula (HFNC), a relatively recent oxygenation device, offers sufficient warm humidity in addition to a high flow of oxygenation and PEEP.

Due to the high gas flow rate, HFNC can create a persistently positive airway pressure effect in the airway, which may have a beneficial physiologic effect.

It is not clear which subgroups of patients could benefit with HFNC or NIV

A recent  study shows NIV with active humidification was superior to HFNC for preventing re-intubation in patients with high-risk of extubation failure.

No study has been made to  see the effects of post extubation NIV with passive humidification in comparison with HFNC in patients with post extubation failure.

Hence this study has been designed to compare NIV with passive humidification to HFNC in patients with postextubation failure.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • critically ill patients who are at high risk of extubation failure.

排除标准

  • Patient who dont give consent for part of study , Do not resuscitate orders, Tracheostomised patients, Age less than 18years, Accidental or self extubation , Do not reintubate orders Contraindication for NIV therapy.

结局指标

主要结局

Reintubation within 48 hours of extubation

时间窗: 48hrs

次要结局

  • Postextubation respiratory failure within 7 days of extubation(Respiratory infection(ventilator associated pneumonia ))

研究者

发起方
Era lucknow medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Nimisha patil

Era lucknow medical college and hospital

研究点 (1)

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