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临床试验/CTRI/2024/11/076867
CTRI/2024/11/076867招募中不适用

Effect of left head rotation versus right head rotation on the efficacy of mask ventilation in apneic adult patients undergoing surgery under general anaesthesia : a prospective randomised crossover study

Dr Harshit Sharma1 个研究点 分布在 1 个国家目标入组 495 人开始时间: 2024年11月27日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
495
试验地点
1
主要终点
1. leak fraction

研究概览

简要总结

This thesis protocol titled “Effect of Left Head Rotation Versus Right Head Rotation on the Efficacy of Mask Ventilation in Apneic Adult Patients Undergoing Surgery Under General Anaesthesia: A Prospective Randomised Crossover Study” by Dr. Harshit Sharma aims to evaluate the impact of different head positions (left vs. right) on the effectiveness of mask ventilation. This prospective, randomized crossover study is designed to measure parameters such as leak fraction, peak inspiratory pressure, and operator ease during mask ventilation with different head rotations.

The study will be conducted at AIIMS Bathinda, including adult patients undergoing general anaesthesia, to determine if left or right head rotation can improve mask ventilation, which is crucial in maintaining a clear airway. This research is particularly relevant due to limited literature on the comparative benefits of head positioning in airway management during anaesthesia. The protocol also outlines rigorous monitoring, consent processes, and ethical considerations for participant safety.

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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adult patients of either gender between 18 and 65 years of age scheduled for elective surgery under general anaesthesia • American Society of Anaesthesiologists (ASA) physical status I, II, III • Body Mass Index between 18.5 to 30 kg/m2 • Neck circumferences less than 40 cm for females and less than 42 cm for males.

排除标准

  • Refusal of consent • Pre-existing Respiratory conditions such as COPD or Restrictive Lung disease • limited head rotation (less than 80 degrees in both directions) and limited neck movements (less than 50 degrees flexion and 80 degrees extension) • Maxillofacial trauma • Edentulous patients • cervical spine pathology • Pregnant patients.

结局指标

主要结局

1. leak fraction

时间窗: average of 12 breaths in each head position

2.peak inspiratory pressure

时间窗: average of 12 breaths in each head position

次要结局

  • operator ease of mask ventilation in different head positions using 5 point likert(scale)

研究者

发起方
Dr Harshit Sharma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr. Harshit Sharma

AIIMS BATHINDA

研究点 (1)

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