跳至主要内容
临床试验/CTRI/2020/12/029692
CTRI/2020/12/029692已完成不适用

Comparison of Cuff Inflation and Conventional Technique for Nasotracheal Intubation using C-MAC Video Laryngoscope. A Prospective Randomised Controlled Trial.

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2021年1月14日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
1
主要终点
Primary outcome of our study is Time taken for ETT placement(defined as time taken after the confirmation of tip of endotracheal tube in nasopharynx by C-MAC video laryngoscope to the appearance of three successive end tidal CO2 waveforms.

研究概览

简要总结

Surgical procedure involving head and neck region, intraoral, maxillofacial and dental procedures usually mandate nasotracheal intubation (NTI). Advantage of NTI is that it better isolates surgical field from artificial airway so that the endotracheal tube is less vulnerable to kinking, damage due to surgical instrumentations. In addition, postoperatively nasal tube is better tolerated than the oral route and require less sedation. Nasotracheal intubation involve passing of tube through one of the nostril till the tube reaches nasopharynx and then with help of video or macintosh laryngoscope it is guided through vocal cord by various manoeuvres like burp, neck movement, tube rotation, use of bougie or by using Magill’s forceps. These manoeuvres lead to longer intubation time, trauma, bleeding of nasopharyngeal wall and hemodynamic stress response while negotiating the tube into trachea. 

Cuff inflation technique (wherein the cuff of ET tube is inflated with air) in which after inflation of the cuff  the endotracheal tube is lifted away from the posterior pharyngeal wall and gets aligned with the laryngeal inlet  and  tip of the tracheal tube is engaged with  the glottis opening. Once the tip of tube passes through the glottis, cuff is deflated and tube is further advanced.

Cuff inflation technique has not been compared with conventional technique yet. Hence, we plan to compare these two techniques of nasal intubation. We hypothesize that cuff inflation technique will have faster intubation time and less manipulation in comparison to conventional nasal intubation technique.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • 1 Patient scheduled for elective surgery requiring nasal intubation 2 American Society of Anaesthesiologists (ASA) physical status 1-2.

排除标准

  • 1 Patient refusal 2 known difficult Airway 3 Patient with mouth opening <2.5cm 4 Patient difficult to mask ventilate 5 History of larynx surgery or larynx radiotherapy 6 Anticipated esophago-tracheal reflux 7 mallampati view 3 or 4 8 Frequent episodes of epistaxis or bleeding tendency 9 patients with significant systemic disease 10 Patient having Contraindications for NTI.

结局指标

主要结局

Primary outcome of our study is Time taken for ETT placement(defined as time taken after the confirmation of tip of endotracheal tube in nasopharynx by C-MAC video laryngoscope to the appearance of three successive end tidal CO2 waveforms.

时间窗: Primary outcome of our study is Time taken for ETT placement(defined as time taken after the confirmation of tip of endotracheal tube in nasopharynx by C-MAC video laryngoscope to the appearance of three successive end tidal CO2 waveforms by the end of 1 minute, beyond one minute attempt is considered a failure.

次要结局

  • 1 Type and number of manoeuvres (M1-M4) used(2 Hemodynamic response to intubation)

研究者

申办方类型
Government medical college

研究点 (1)

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