跳至主要内容
临床试验/CTRI/2025/12/099711
CTRI/2025/12/099711尚未招募2 期

A Randomized controlled study of neonates undergoing endotracheal intubation with high nasal flow oxygen VS standard care

DrHima Chandana Mankala1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月10日最近更新:

试验速览

阶段
2 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 observe first successful intubation attempt in neonates undergoing endotracheal intubation with high nasal flow oxygen vs neonates receiving standard care

研究概览

简要总结

This study aims to evaluate the effectiveness of high-flow nasal oxygen in improving the success of the first endotracheal intubation attempt in neonates, compared with standard care. By closely observing clinical outcomes in both groups, the study seeks to determine whether the continuous oxygen delivery provided by high-flow nasal therapy helps maintain better oxygenation and physiological stability during the procedure. The investigation will assess not only the rate of first-attempt success but also associated factors such as heart rate changes, oxygen desaturation episodes, and overall intubation conditions. Through this comparison, the study intends to generate evidence on whether integrating high-flow nasal oxygen into neonatal airway management can enhance procedural safety and reduce complications during intubation.

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
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • all eligible neonates undergoing endotracheal intubation in KIMS NICU.

排除标准

  • infants with oromaxillary and airway anomalies.

结局指标

主要结局

to observe first successful intubation attempt in neonates undergoing endotracheal intubation with high nasal flow oxygen vs neonates receiving standard care

时间窗: to observe first successful intubation attempt in neonates undergoing endotracheal intubation with high nasal flow oxygen vs neonates receiving standard care immediately after the intubation attempt -10 mins

次要结局

  • To assess if time to desaturation is prolonged with high nasal flow oxygen via nasal prongs(10 mins of study)

研究者

发起方
DrHima Chandana Mankala
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

HIMA CHANDANA MANKALA

KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES

研究点 (1)

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