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临床试验/CTRI/2024/08/072151
CTRI/2024/08/072151尚未招募4 期

Comparison of Laryngeal mask airway Blockbuster and Laryngeal mask airway Supreme in patients undergoing General Anesthesia A Randomised Controlled Trial

Rohilkhand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年8月19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
72
试验地点
1
主要终点
1. Number of attempts

研究概览

简要总结

General anesthesia is described as a state of "Controlled Unconsciousnes allowing patients to undergo procedures that would be unbearable while awake. Ensuring a secure airway is crucial during general anesthesia to ensure proper ventilation, oxygenation, and administration of anesthetic gases.

The management of the airway is vital in both general anesthesia and resuscitation efforts. Endotracheal intubation, which requires a deeper level of anesthesia and greater expertise, is associated with a higher incidence of postoperative sore throat. In response to this challenge, a significant innovation emerged in 1981 with the introduction of the Laryngeal-mask airway by Dr. Archie Brain.

Supraglottic airway devices have become increasingly prevalent in airway management due to their advantageous anatomical placement and minimally invasive characteristics. These devices serve as a link between traditional face masks and tracheal tubes, positioned above the glottis, eliminating the need to enter the trachea. They provide a hands-free technique for securing the airway, enabling efficient ventilation, oxygenation, and administration of anesthetic gases without the requirement for tracheal intubation.

Supraglottic Airway (SGA) devices offer a more secure airway than a face mask and are less intrusive than tracheal intubation. They can be used for both spontaneous ventilation and Positive Pressure Ventilation. They also offer several advantages, such as rapid and uncomplicated placement, enhancement of hemodynamic stability, reduced anesthesia requirements, elimination of the need for muscle relaxation, and avoidance of certain risks associated with tracheal intubation. These risks include potential harm to teeth and airway structures, the occurrence of a sore throat, emergence-related coughing, and bronchospasm. Additionally, SGA devices offer an enhanced airway seal, achieved through improved seal materials or design, which simplifies intubation by allowing the use of regular endotracheal tubes and incorporates a gastric access port for venting and aspirating stomach contents.

The LMA BLOCKBUSTER, developed by Prof. Ming Tian, is part of the second generation of LMAs. It serves as a well-tolerated airway device with the capability for tracheal intubation. Featuring an intubation channel, it enhances the success rate of blind tracheal intubation while ensuring a secure seal and extended ventilation. Made from flexible and biocompatible silicone material, this laryngeal mask includes an inflatable cuff and is angled over 95 degrees for optimal placement. To ensure safety, a gastric tube can be inserted alongside to prevent gastric reflux and aspiration. It also includes features like an integrated bite block and sputum collection device. Additionally, it comes with an endotracheal tube featuring a Parker pen tip and an exchange guide.

LMA SUPREME is a single-use, latex-free laryngeal mask airway made of medical grade PVC. It combines features from various LMA designs. The device features an inflatable and large plastic cuff without a posterior cuff, an esophageal drain tube, and a pre-formed semi-rigid tube. Fins in the mask bowl help prevent epiglottic obstruction. Its pharyngeal seal is intermediate between cLMA and PLMA, while the oesophageal seal data is not available. The firm, elliptical, and anatomically shaped airway tube allows for easy insertion without requiring fingers in the patient’s mouth or an introducer tool.

Supraglottic airway devices (SADs) are frequently employed as alternatives to both face mask ventilation and tracheal intubation. However, there remains a lack of extensive research regarding the safety and efficacy of SADs like LMA Blockbuster and LMA Supreme. To bridge this knowledge gap, we are proposing a randomized controlled trial to compare the performance of LMA Blockbuster and LMA Supreme in patients undergoing 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 65.00 Year(s)(—)
性别
All

入选标准

  • Either sex.
  • BMI less than 26kg/m2 Mallampati classification I & II ASA- I & II Age- 18 to 65 years Adequate head & movement.

排除标准

  • Anticipated difficult airway Full stomach patients Cervical spine instability Temporomandibular joint pathology History of gastro-oesophageal reflux or increased risk of Gastric aspiration Pharyngeal & Laryngeal surgery Thoracotomy Lateral or prone surgery position Pregnant females.

结局指标

主要结局

1. Number of attempts

时间窗: Baseline, 5 minutes, 10 minutes, 15 minutes, postoperative time

2. Ease of insertion

时间窗: Baseline, 5 minutes, 10 minutes, 15 minutes, postoperative time

3. Airway manipulation

时间窗: Baseline, 5 minutes, 10 minutes, 15 minutes, postoperative time

4. Oropharyngeal seal Pressure 5. Post-operative Pharyngolaryngeal Morbidity

时间窗: Baseline, 5 minutes, 10 minutes, 15 minutes, postoperative time

6. Ease and time of insertion of gastric tube

时间窗: Baseline, 5 minutes, 10 minutes, 15 minutes, postoperative time

7. ETCO2 Graph (Capnography characteristics)

时间窗: Baseline, 5 minutes, 10 minutes, 15 minutes, postoperative time

次要结局

  • Hemodynamic parameters (Heart rate, systolic & diastolic blood pressure, mean arterial pressure)(Baseline, 5 minutes, 10 minutes, 30 minutes & at the end of surgery)

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 Richa Chandra

Rohilkhand Medical College and Hospital

研究点 (1)

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