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临床试验/CTRI/2024/09/073673
CTRI/2024/09/073673尚未招募4 期

Comparison of Laryngeal Mask Airway Protector versus Laryngeal Mask Airway Blockbuster in Patients undergoing General Anaesthesia: A Randomised Control Study

Rohilkhand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年9月20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
66
试验地点
1
主要终点
1.Time taken for insertion of Supraglottic Airway Devices.

研究概览

简要总结

Securing airway is of critical importance in patients undergoing surgeries and its maintenance is essential for stability of the patient during surgery. The airway management serves as the foundation on which efficacy and safety of anesthesia practice are built. Laryngeal Mask Airway (LMA) is an important tool used for maintenance of airway. Such devices revolutionized the practice which were introduced by Archie Brain and it was less stressful than tracheal intubation to the patients. It was as safe as using a facemask and airway. These are commonly employed in anaesthetic, critical care, and emergency scenarios for managing the airway. It also excels in managing challenging airways. It offers advantage of avoiding endotracheal intubation and provides a shorter insertion time as well as it has lower incidence of post-operative pharyngeal pain, and better hemodynamic stability during induction and emergence.

The mechanism of action of LMAs is through the creation of a low-pressure seal around the laryngeal inlet which permits positive pressure ventilation. This design minimizes the need for neuromuscular blockade and allows for a smoother airway management process, particularly in cases where intubation may be challenging or unnecessary. Over the years, various LMA devices have been developed. Each with specific features are designed to improve its ease of use, safety, and effectiveness. These range from the classic LMA, flexible LMA, to more recent LMAs such as the LMA Supreme, LMA ProSeal, LMA protector and last but not the least LMA Blockbuster.

Among these, One notable device in this group is the LMA Protector, which stands out due to its advanced features that aim to improve patient safety and make it easier to insert. The LMA Protector, with its dual gastric access channels and cuff pressure monitoring capabilities, represents a significant advancement in LMA technology. The device is designed to offer superior protection against aspiration, a critical consideration in anesthesia management. However, despite its advantages, the LMA Protector is not without challenges. Issues such as the need for precise placement, potential for increased costs, and the requirement for training to optimize its use are notable concerns.

A revolutionary second generation LMA known as the Blockbuster LMA developed by Prof. Ming Tian in 2012. The LMA BlockBuster represents another significant advancement in airway management technology. The  LMA BlockBuster incorporates features that address some of the limitations observed in earlier LMA designs. Its peculiarities, such as enhanced seal pressure capabilities and improved ease of insertion, contributed to its growing popularity. The LMA BlockBuster’s design focuses on providing a high degree of airway security and ventilation efficiency.

Comparing the LMA Protector and LMA BlockBuster reveals significant differences that influence their use in anaesthesiology. The LMA Protector’s dual-channel design offers unique advantages in managing gastric contents and monitoring cuff pressure, potentially reducing the risk of aspiration. In contrast, the LMA BlockBuster, with its focus on ease of insertion and high seal pressures, may be preferred in scenarios where rapid and reliable airway management is critical. The choice between these devices often depends on specific patient conditions, surgical requirements, and the anaesthesiologist’s expertise and preference.

Despite the advancements and the availability of various LMA devices, there remains a knowledge gap in the literature concerning the comparative effectiveness, safety, and applicability of the LMA Protector versus the LMA BlockBuster. Despite the extensive research being undertaken on the topic of various LMAs, the comparison between LMA Protector and LMA BlockBuster remains scarce. There is hardly any study that has come up with such comparison.  There is a need for a comprehensive and well-designed comparative study addressing these two LMAs.

With this background we undertook this study to compare the safety and efficacy between LMA Protector and LMA Blockbuster in providing airway management for patients undergoing surgeries under general anesthesia.

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

  • 1.Patients undergoing elective surgeries under general anesthesia
  • Age between 18 to 60 years
  • ASA physical status of I or II 4.Mallampati Classification (MMT) of I & II
  • BMI ≤ 30 kg/m².

排除标准

  • Morbid Obesity, Pregnancy.
  • Patient with neck pathology
  • Anticipated difficult airway
  • Pre-existing cervical spine disease
  • History of gastro-oesophageal reflux or increased risk of Gastric aspiration.
  • Lesion in oral cavity
  • Loose denture
  • Head & Neck surgeries.

结局指标

主要结局

1.Time taken for insertion of Supraglottic Airway Devices.

时间窗: Before LMA insertion, At the time of LMA Insertion, every 5 minutes after LMA insertion till 60 minutes , then every 10 minutes and immediately after the removal of the device.

2.Total number of attempts

时间窗: Before LMA insertion, At the time of LMA Insertion, every 5 minutes after LMA insertion till 60 minutes , then every 10 minutes and immediately after the removal of the device.

3.Ease of Insertion

时间窗: Before LMA insertion, At the time of LMA Insertion, every 5 minutes after LMA insertion till 60 minutes , then every 10 minutes and immediately after the removal of the device.

4.Oropharyngeal seal pressure

时间窗: Before LMA insertion, At the time of LMA Insertion, every 5 minutes after LMA insertion till 60 minutes , then every 10 minutes and immediately after the removal of the device.

5.Blood stain on the device

时间窗: Before LMA insertion, At the time of LMA Insertion, every 5 minutes after LMA insertion till 60 minutes , then every 10 minutes and immediately after the removal of the device.

6.Sore throat

时间窗: Before LMA insertion, At the time of LMA Insertion, every 5 minutes after LMA insertion till 60 minutes , then every 10 minutes and immediately after the removal of the device.

7.Airway trauma

时间窗: Before LMA insertion, At the time of LMA Insertion, every 5 minutes after LMA insertion till 60 minutes , then every 10 minutes and immediately after the removal of the device.

次要结局

  • Hemodynamic parameters like Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure(MAP), Heart Rate(HR), SpOâ‚‚(Before LMA insertion, At the time of LMA Insertion, every 5 minutes after LMA insertion till 60 minutes , then every 10 minutes and immediately after the removal of the device.)

研究者

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

Dr Ankur Garg

Rohilkhand Medical College and Hospital

研究点 (1)

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