跳至主要内容
临床试验/CTRI/2024/07/071669
CTRI/2024/07/071669尚未招募2/3 期

Efficacy of Baska Mask versus Proseal Laryngeal Mask Airway in elective surgeries under general anesthesia - a Randomized Controlled Trial

Dr. R. Ajisha Rachel1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To measure time taken for insertion, ease of insertion and number of attempts for insertion between the Proseal Laryngeal Mask Airway and the Baska Mask

研究概览

简要总结

The supraglottic airway devices (SAD) have drastically changed the face of airway management in patients undergoing anesthesia and have become a key component of modern airway management, especially in surgeries of short durations.

The Proseal Laryngeal Mask Airway (PLMA) is a reusable second generation SAD with an additional inflatable dorsal cuff, integrated bite block, and a gastric drain tube, while the Baska Mask (BM), a third generation SAD, possesses newer modified features such as a sump with two drains and a bite block throughout the entire length of the airway tube, which would lead to better clinical performance than the PLMA.

This study aims to compare the advantages and efficacy of Baska Mask (BM) over Proseal Laryngeal Mask Airway (PLMA) ) in adult patients undergoing elective surgery under general anesthesia with controlled ventilation.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of either gender, from 18 to 60 years of age, belonging to the American Society of Anesthesiologists (ASA) classes I, II and III.

排除标准

  • Patients refusal, BMI more than or equal to 30 kg per metre square, Restricted mouth opening, Surgeries lasting more than 2 hours, Burns and swelling in neck, High aspiration risk with poor pulmonary compliance.

结局指标

主要结局

To measure time taken for insertion, ease of insertion and number of attempts for insertion between the Proseal Laryngeal Mask Airway and the Baska Mask

时间窗: At start of insertion of both devices

次要结局

  • To measure oropharyngeal seal pressure (OSP) logged at two different times and post- insertion(complications between Baska Mask and Proseal Laryngeal Mask Airway)

研究者

发起方
Dr. R. Ajisha Rachel
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr R Ajisha Rachel

Sri Venkateshwaraa Medical College Hospital and Research Centre

研究点 (1)

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