跳至主要内容
临床试验/CTRI/2022/05/042859
CTRI/2022/05/042859已完成不适用

Positive Predictive Value of the Presence of Endotracheal(ETT) cuff ballotability above the Suprasternal notch in diagnosing the Correct positioning of ETT(PRESeNCE)-A prospective Observational study

PGIMER1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2022年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
PGIMER
入组人数
76
试验地点
1
主要终点
To determine whether the Endotracheal tube(ETT) cuff ballotability over the suprasternal notch accurately predicts the correct placement of ETT.

研究概览

简要总结

Endotracheal intubation is one of the most common procedures used by anesthesiologists, intensivists and emergency personnel. But it can be associated with complications, such as carinal impingement or endobronchial intubation, which leads to increased incidence of barotrauma, contralateral lung collapse, or both, which result in hypoxemia and hemodynamic instability.

Three types of malposition can occur during intubation: one outside the trachea (esophageal), and two within the trachea: too shallow (hypopharyngeal/transglottic cuff), or too deep (endobronchial).

The various other methods for determining Endotracheal tube(ETT) placement are bilateral chest auscultation of equal air entry, chest X ray, fiberoptic bronchoscopy, capnography. However, these techniques are quite limited in actual clinical practice.

Ballotability of the ETT cuff over the anterior part of trachea above the supersternal space of Burns, could be a novel technique to confirm the proper ETT position.

Hence considering the simplicity of this test and its bedside/point of care utility, we

propose to investigate this method of cuff ballotment to verify the correct ETT

position and to explore its sensitivity, specificity, positive and negative predictive

value when compared with the gold standard of cervicothoracic Xray.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Patients who are undergoing any procedure in Digital Subtraction Angiography(DSA) suite under General Anesthesia.
  • •BMI< 30 kg/m2.

排除标准

  • •Obesity Cervical collar in place Presence of mass in front of neck Previous history of radiation to neck Patient refusal to study Inability to visualise the Endotracheal tube cuff in x ray/ fluoroscopy.

结局指标

主要结局

To determine whether the Endotracheal tube(ETT) cuff ballotability over the suprasternal notch accurately predicts the correct placement of ETT.

时间窗: single time, with the data collected after the induction of General Anesthesia in all subjects.

次要结局

  • To find the Positive Value of the Presence of endotracheal tube cuff ballotability above the Suprasternal notch for correct positioning of the ETT.(1)
  • To find the sensitivity and specificity of cuff ballotability for correct positioning of ETT.(Single time, done with the data collected after induction of general anesthesia in patients.)

研究者

发起方
PGIMER
申办方类型
Research institution

研究点 (1)

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