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临床试验/CTRI/2025/04/084952
CTRI/2025/04/084952尚未招募3 期

Prospective study to compare the Blockbuster LMA and the Air Q LMA as a conduit for blind tracheal intubationin patients scheduled for elective surgery under general anaesthesia

Doctor Sapna Bansal HOD and Professor of Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年4月27日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
To study the comparion of successful intubations, time taken for intubation, number of attepmts and post operative complications

研究概览

简要总结

Airway management remains a vital primary skill for anaesthetist. Rapid placement of a reliable airway is the most important task in anesthesia practice. Airway management is a critical skill to provide safe anesthesia . Airway management in patients undergoing general anesthesia is a set of actions that result in the creation of a safe and secure airway for ventilation. Failure in the airway management and hypoxia can lead to irreversible brain damage within only a few minutes. Therefore, establishing a fast and secure airway is one of the most important tasks of an anesthesiologist.

The main reason for failure in laryngoscopy is the anatomical condition of the patient and the physician’s experience in performing a laryngoscopy. The availability of alternative equipment and methods may increase the success rate for anesthesiologists.

Many devices and instruments have been introduced and used to make intubation an easier and simple technique. In the events of failure to intubate and failure to ventilate, LMA play a critical role. LMA are inserted up to glottic entry via oral route and can be used in conditions when tracheal intubations and mask ventilations are challenging. Over the years, the single-tube supraglottic airway device (SGD) design transformed into dual-lumen intubating conduits and assumed an advanced role in airway management. New SGDs have roles beyond airway maintenance, including airway rescue after failed intubation or failed ventilation.

SGDs are recommended to be used as intubation conduits by Difficult airway society guidelines. With the availability of different intubating SGD designs over the years, it is essential to understand which device serves as a better intubating conduit.

Blockbuster LMA (Tuoren medical instrument co ltd, Chang yuan city, China) introduced in 2012 by Professor Ming Tian, is designed to provide high airway seal pressures and increased green channel for intubation.(2)

  1. Air Q LMA (Cook gas LLC, Mercury Medical, Clearwater, FL, USA) introduced by Daniel Cook in 2005 is a supraglottic airway device with shorter and wider breathing tube designed for ventilation as well as intubation in anticipated as well as unanticipated difficult airway. The design of both these LMAs provide an unobstructed pathway for passage of endotracheal tube by providing favorable alignment with the glottic inlet. It is necessary to assess their safety and their performance . Many authors have studied regarding the utility of blockbuster LMA and Air Q LMA separately. However, there is a paucity in the literature in regards to comparing the above devices in regards to success of endotracheal intubation. Therefore, the purpose of conducting this study is to compare the efficacy of blind endotracheal intubation through Blockbuster and Air Q LMA in terms of successful tracheal intubation, time taken for intubation, number of attempts and post operative complications associated.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant, Investigator and Outcome Assessor 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

  • Either gender of age 18-60 years and ASA grade I and II status with modified Mallampatti grade I,II or III, scheduled for elective surgery under general anaesthesia.

排除标准

  • ASA III and IV
  • Obese patients with BMI >40
  • Anticipated difficult airway (Incisior distance <3cm, MPG grade IV, restricted neck movements)
  • ptients refused to give consent.
  • pregnant females
  • those planned for rapid sequence intubation
  • increased risk of pulmonary aspiration with gastric content
  • patients with complaints of sore throat, oral or laryngeal pathology.

结局指标

主要结局

To study the comparion of successful intubations, time taken for intubation, number of attepmts and post operative complications

时间窗: Peroperative( baseline), at the time of intubation , 1 min after Endotracheal tube insertion, 3 min after ETT insertionn and 5 min after ETT insertion

次要结局

  • to study ease of insertion of ETT via LMA & to detect failure of LMA insertion or ETT insertion.(preoperative(baseline) vitals measurement, intubation via alternate mathods & time taken, post operative vital measurement)

研究者

发起方
Doctor Sapna Bansal HOD and Professor of Department of Anaesthesia
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Pranya Singla

Maharishi Markandeshwar University

研究点 (1)

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