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临床试验/NCT05439109
NCT05439109Unknown不适用

To Evaluate the Appropriate Depth of Endotracheal Tube Placement Guided by Topographical Landmarks

Rajiv Gandhi Cancer Institute & Research Center, India2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
2
主要终点
Endotracheal tube position inside the trachea

研究概览

简要总结

An optimal endotracheal tube depth is ideally required for preventing the complications associated with mal-positioning of the endotracheal tube. The topographical technique of tube placement considering the individual's morphometric dimensions could help to provide optimal tube placement. hence, to evaluate the efficacy of the topographical technique in providing the optimal tube placement this study will be conducted.

详细描述

The trachea is a dynamic organ and its length varies by various static and dynamic factors leading to changing the tracheal length and variable endotracheal tube tip to carina (Ti-Ca) distance. Hence, upholding optimal Ti-Ca distance during changing tracheal length is of utmost importance to prevent complications associated with endotracheal tube (ETT) mal-positioning. When the length of ETT, which is to be inserted inside the trachea, is calculated as per an individual's tracheal morphometric dimensions, the appropriate depth of placement could be achieved and tube malpositioning can be prevented. In the topographical landmark technique, an individual tracheal length is estimated by measuring the various distance from mid-thyroid level (corresponds to vocal cords) to manubriosternal joint (corresponds to carina) in the sagittal plane. After estimating the tracheal length, tip to carina distance of 3cm was deducted from the estimated length of the trachea to provide the distance of the endotracheal tube to be kept beyond the vocal cords. Hence, the investigators planned this study to find the "utility and reliability" of the topographical landmark technique compared to the conventional intubation guide mark technique in providing the appropriate depth of endotracheal tube placement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The primary investigator will provide the information regarding the portion of endotracheal to be kept below the vocal cords to the care provider after measuring the dimensions of the trachea topographically. After tube placement, the tube tip to carina distance will be measured in both topographical and intubation guide mark technique.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Age group of 18-75 years
  • ASA physical status I-III patients
  • Oral intubation for general anesthesia

排除标准

  • • Patient with upper airway fibrosis
  • Tracheal stenosis or tracheal surgeries
  • Previous head and neck surgeries
  • Contracture neck or irradiated neck
  • Large neck swelling distorting or deviating the trachea
  • Laryngeal or tracheal tumor
  • Intubations requiring flexo-metallic tubes
  • Patient refusal

结局指标

主要结局

Endotracheal tube position inside the trachea

时间窗: through study completion approximately at six months

Tip to carina distance will be measured by fiber optic bronchoscopy to classify the optimal or suboptimal tube placements in both groups

次要结局

未报告次要终点

研究者

发起方
Rajiv Gandhi Cancer Institute & Research Center, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Amit Kumar Mittal

Principal Investigator

Rajiv Gandhi Cancer Institute & Research Center, India

研究点 (2)

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