CTRI/2024/06/068309尚未招募1/2 期
A Prospective Randomized Study ProSeal Laryngeal Mask Airway Placement Videolaryngoscpe-Guided Versus Classic Digital Technique
Harnoor Singh1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月10日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the number of attempts, insertion time, leak volume, fibreoptic score, peak inspiratory pressure, to insert ProSeal LMA with videolaryngoscope D blade versus classic digital technique.
研究概览
简要总结
The Purpose Of This Randomised Prospective Clinical Trial Is To Evaluate The Effectiveness Of Two Different Insertion Techniques Of ProSeal LMA That Is Videolaryngoscope Guided Insertion Versus Classic Digital Insertion Technique
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 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
- •1.Patients with physical status ASA grade I or II.
- •2.All patients giving written informed consent.
- •3.Patients undergoing lower abdominal elective surgery under general anaesthesia.
- •4.Patients belonging to age group of 18 to 65 years.
排除标准
- •Patient refusal for the procedure.
- •Patient with anaemia.
- •ASA grade 3 and 4
- •Patient with significant coagulopathies.
- •Patient with known or suspected pregnancy.
- •Patient with renal or liver disease.
- •Non fasting patients.
- •Patients on antipsychotic medication.
- •Patients with increased risk of aspiration.
- •Patients with BMI more than 35 kg per square meter
- •Patients with difficult airway.
- •Patients with pre-existing sore throat or hoarseness.
结局指标
主要结局
To compare the number of attempts, insertion time, leak volume, fibreoptic score, peak inspiratory pressure, to insert ProSeal LMA with videolaryngoscope D blade versus classic digital technique.
时间窗: Number of attempts to insert ProSeal LMA -3 attempts | Insertion time of ProSeal LMA-3minutes | Leak volume at 15 minutes | Fibre optic score at 3 minutes | Peak inspiratory pressure at 15 minutes | Oropharyngeal leak at 15 minutes
次要结局
- 1. To compare the hemodynamic changes HR, SBP, DBP, MAP, SpO2 at various time intervals in both study groups.(2. To compare the complications and adverse effects of both the insertion techniques.)
研究者
Harnoor Singh
Post Graduate Student MMIMSR
研究点 (1)
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