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临床试验/CTRI/2025/09/094130
CTRI/2025/09/094130尚未招募4 期

To compare the efficacy of HFNO with bag mask ventilation for preoxygenating the obese patients posted for surgeries under general anaesthesia using ORI – A randomized controlled trial

AIIMS MANGALAGIRI1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Time to achieve optimal ORI level of 0.3

研究概览

简要总结

Endotracheal intubation necessitates an anaesthetic induction that leads to loss of consciousness and neuromuscular paralysis. This process can cause hypoventilation and apnea, increasing the risk of hypoxia, especially in challenging intubation scenarios. As a result, it is essential to perform careful preoxygenation when the patient is breathing spontaneously. This step is particularly vital for managing airway control in obese patients, who are more susceptible to hypoxia during anaesthesia induction. While traditional techniques like bag-mask ventilation (BMV) have been commonly used, newer approaches such as high-flow nasal oxygen (HFNO) are becoming more popular due to their advantages in enhancing oxygenation and reducing the likelihood of desaturation.

Obesity and Anaesthesia Challenges: Obesity significantly alters respiratory physiology, leading to decreased functional residual capacity, increased oxygen consumption and impaired airway mechanics. These factors increase the likelihood of perioperative complications, particularly during periods of apnoea that occur during intubation. Effective preoxygenation is essential to enhance the safety of anaesthesia induction in this population.

Pulse oximeter provides no indication of downward trends in PaO2 until saturation begins to fall. The ORI is a novel pulse oximeter–based non dimensional index that ranges from 0 to 1 correlating PaO2 from 80 to 200 mmHg and is measured by optically detecting changes in SvO2 once SaO2 saturates to the maximum. Therefore during a crisis, having a reliable estimate of time remaining, before hypoxemia ensues, would help guide management.

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Obese patients posted for surgeries under general anaesthesia , BMI more than 30 kg per m².

排除标准

  • History of respiratory failure or significant pulmonary disease , Severe cardiovascular comorbidities , Any pathology involving nasal passage (polyp, inferior turbinate hypertrophy etc.),Pregnant women.

结局指标

主要结局

Time to achieve optimal ORI level of 0.3

时间窗: 0,30 sec ,60 sec,90 sec,120 sec , 180 sec

次要结局

  • Comfort & tolerability during preoxygenation(Post operatively 15 min after emergence from anesthesia)
  • To monitor any adverse events or complications.(Post-operatively 0,15 min after emergence from anesthesia)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Samarjit Dey

AIIMS Mangalagiri

研究点 (1)

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