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临床试验/CTRI/2024/11/076346
CTRI/2024/11/076346尚未招募4 期

Comparison of D-Stylet and rigid stylet using videolaryngoscope in difficult intubation

Dayanand Medical college and Hospital1 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2024年11月21日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
232
试验地点
1
主要终点
Comparison of successful Endotracheal tube time between videolaryngoscopic inubation using D Sylet and Portex Rigid Stylet

研究概览

简要总结

The use of stylet with an endotracheal tube (ETT) in anticipated difficult airway patients using videolaryngoscope(VL) has decreased the incidence of failed intubations. Commonly used Portex® rigid stylet forms a fixed shape and curvature of ETT, which at times does not match with the angle and curvature of the D-blade C-MAC videolaryngoscope. This necessitates the withdrawal of ETT-stylet assembly for reshaping. On the other hand, the D-stylet has an easily controllable flexible tip, which can be used as a dynamic aid to tailor the ETT shape and its tip can be altered as required by the intubating personnel according to the angle of the D-Blade. A prospective, interventional, single-blinded study will be conducted on a total of 232 patients having anticipated difficult airway undergoing elective tracheal intubation with a D-blade videolaryngoscope. The patients will be divided into the following two groups- In group D intubation will be done on 116 patients using D-Stylet while Portex® rigid stylet will be used in Group P on the other 116 patients. Aim of our study is the Comparison of D-stylet with rigid stylet as a dynamic aid to facilitate intubation in anticipated difficult airway using a D-blade videolaryngoscope. The primary outcome of our study is difference in ETT negotiation time between both groups and the secondary outcome is difference in total intubation time, number of attempts for successful intubation, hemodynamic changes, and any airway trauma between both the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Age more than or equal to 18 yrs 2.Either sex 3.American Society of Anaesthesiologists grade 1-4 4.Patients with Anticipated difficult airway more than 6.

排除标准

  • 1.Known airway pathology 2.Head and neck known malignancy 3.Immobilized cervical spine 4.Pregnancy 5.Increased risk of regurgitation and aspiration of gastric contents 6.Patient refusal.

结局指标

主要结局

Comparison of successful Endotracheal tube time between videolaryngoscopic inubation using D Sylet and Portex Rigid Stylet

时间窗: Time used between receiving the styleted endotracheal tube in the laryngoscopists hand and the successful passage of black line on endotracheal tube just beyond the vocal cord, measured in seconds.

次要结局

  • Difference in total intubation time, number of attempts for successful intubation, hemodynamic changes, and any airway trauma between both the groups(Total intubation time- From start to end of intubation procedure.)

研究者

发起方
Dayanand Medical college and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shikha Gupta

Dayanand Medical College and Hospital

研究点 (1)

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