Comparative study of the efficacy of Baska mask vs Endotracheal tube in adult women undergoing elective laparoscopic surgeries
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To conclude the effect of Baska mask and endotracheal tube over hemodynamic parameters.
研究概览
简要总结
Abstract:
Background:
The endotracheal tube (ETT) has traditionally been the established method for maintaining airway safety. However, applying excessive pressure with cuffed tubes can lead to decreased blood flow to the airway lining and subsequently result in injury.
The LMA offers numerous advantages when compared to the ETT. These benefits include avoiding direct contact with the tracheal lining, eliminating the need for direct laryngoscopy during insertion, and reducing the occurrence of adverse events such as less frequent coughing, enhanced oxygen saturation during the recovery period, and a lower likelihood of adults experiencing a sore throat.
The Baska mask is a type of supraglottic airway device that incorporates a seamless, non-inflatable flexible cuff designed to imitate an airway. This design serves to reduce the chances of overinflation and lowers the risk of aspiration of gastric contents.
This study aims to compare the efficacy of Baska mask and endotracheal tube in adult women undergoing laparoscopic surgeries.
Aim:
To compare the efficacy of Baska mask and Endotracheal tube in adult women undergoing laparoscopic surgeries
Primary objective:
To compare the effect of Baska mask and endotracheal tube over hemodynamic parameters like heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure and SPO2.
Secondary objectives:
1. To compare the airway responses like mean airway pressure and End tidal CO2
2. To compare the time of insertion
Materials and methods:
A total of 30 female patients with mouth opening more than or equal to 3 fingers and undergoing laparoscpic surgery will be allotted into two groups. The study will be conducted in AVBRH, Sawangi. Group A will be intubated with adequate size endotracheal tube and Group B will receive adequate size Baska mask. Hemodynamic parameters and airway responses will be monitored and the time take and ease of intubation will be compared between both the groups.
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 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female patients aged between 18-70 years of age.
- •2.ASA Class I & II patients.
- •3.All patients willing to give informed consent.
- •Mouth opening more than or equal to 3.
排除标准
- •1.ASA Class III and above.
- •2.Patients’ refusal.
- •3.Age less than 18 years and more than 70 years.
- •4.Male gender.
- •5.Patients having contraindications with laparoscopic surgeries.
- •6.Patients having allergic reactions to general anaesthetic agents.
- •7.Mouth opening less than 3 fingers.
- •8.Intraoperative use of airway devices other than endotracheal tube.
结局指标
主要结局
To conclude the effect of Baska mask and endotracheal tube over hemodynamic parameters.
时间窗: 1. Baseline | 2. At induction | 3. 5 minutes after induction | 4. 10 minutes after induction | 5. 15 minutes after induction
次要结局
- To conclude which among the two groups has the minimum airway responses and minimum time of insertion
研究者
Dr Poornima D
Jawaharlal Nehru Medical College,Datta Meghe Institute of Higher Education and Research