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临床试验/CTRI/2019/09/021358
CTRI/2019/09/021358已完成不适用

“COMPARATIVE EVALUATION OF EASE OF OROTRACHEAL INTUBATION USING C-MAC® VIDEO LARYNGOSCOPE VERSUS McGRATH®MAC VIDEO LARYNGOSCOPE IN PATIENTS UNDERGOING ELECTIVE SURGERIESâ€A PROSPECTIVE RANDOMIZED STUDY

Institutional ESI PGIMSR and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年3月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Ease of orotracheal tube placement using C-MAC® video laryngoscope and McGRATH® MAC video laryngoscope.

研究概览

简要总结

Airway management is one of the most important skills in the field of anaesthesiology.Endotracheal intubation with the help of Macintosh laryngoscope is a gold standard for definitive airway management in patients undergoing surgery requiring general anesthesia.In recent years, video laryngoscopes have gained in popularity. Video laryngoscopy-assisted tracheal intubation has extensively been applied in airway management because of several significant advantages. These include:(1) improved laryngeal visualization without the need for aligning three axes (oral, pharyngeal and laryngeal axes) especially in difficult airway conditions. (2) The high-quality, magnified airway image makes it easy to identify the airway anatomical structures and anomalies, and facilitates manipulation of airway devices. (3) The entire team can see laryngoscopy and intubation process on the monitor, rather than only the intubator. The multi-person visualization feature can facilitate communication and cohesion of team, improve coordination between intubator and assistant.    Non-handle mounted video laryngoscope, that is, C-MAC® video laryngoscope was developed and manufactured by the Karl Storz GmbH & Co. KG (Tuttlingen, Germany) in 1999. Handle mounted video laryngoscope, that is, McGRATH® MAC (Aircraft Medical Edinburgh, Scotland) is a novel, self-contained video laryngoscope, containing a sterile, transparent, single-use blade. The video laryngoscope was originally designed as a device to manage difficult intubation with direct laryngoscopy. Success with the application of any device can be enhanced as experience with the intervention accumulates. If video laryngoscopy is used for all patients, experience and skill would undoubtedly increase, the number of intubation attempts and complications of multiple attempts would decrease, and patient care would improve. It has been suggested that optimal video laryngoscope should be offered to all patients without significant limitations and not restricted to only those considered most difficult.As video laryngoscopes are introduced into clinical practice, it is important to evaluate their clinical performance and safety to establish superiority or equivalence to already existing devices.There are few published studies with regard to comparison of C-MAC® video laryngoscope (non-handle mounted video laryngoscope) and McGRATH® MAC video laryngoscope (handle mounted video laryngoscope) around the world but no such study has been conducted in India.Hence, this study is planned to be conducted in a prospective, randomized manner to compare C-MAC® video laryngoscope and McGRATH® MAC video laryngoscope for their use in patients undergoing elective surgery under general anesthesia in adult Indian population.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • INCLUSION CRITERIA Patients with ASA grade I / II Age 18-60 years of either sex Patient undergoing elective surgeries requiring general anaesthesia and orotracheal intubation.

排除标准

  • EXCLUSION CRITERIA Patient refusal.
  • Patients having: Modified Mallampatti class III or IV Mouth opening < 2.5cm Interincisor distance < 3.5 cm Thyromental distance < 6 cm Sterno-mental distance < 12 cm Mandibulo-hyoid distance < 4 cm Cervical spine instability BMI >30 kg/m2 Risk of gastric aspiration Edentulous patients and patients having artificial denture will be excluded from the study.

结局指标

主要结局

Ease of orotracheal tube placement using C-MAC® video laryngoscope and McGRATH® MAC video laryngoscope.

时间窗: Time (in seconds) to intubate the trachea, starting from picking up the video laryngoscope | to successful placement of endotracheal tube as confirmed by auscultation of breath sounds, and | presence of square wave capnography on monitor will be noted. If more than one intubation attempt is required, time from insertion of the laryngoscope for the first intubation attempt until confirmation of successful intubation by capnography will be considered to be the total intubation time.

次要结局

  • 1.Time (in seconds) taken for orotracheal intubation using C-MAC® video laryngoscope and McGRATH® MAC video laryngoscope.(2.Hemodynamic effects and oxygen saturation changes during orotracheal intubation using C-MAC® video laryngoscope and McGRATH® MAC video laryngoscope.)

研究者

发起方
Institutional ESI PGIMSR and Hospital
申办方类型
Research institution and hospital

研究点 (1)

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