Comparison of the clinical performance of the two second generation supraglottic airway devices (I-GEL VS AMBUAURAGAIN) in adult patients undergoing elective surgery.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- QUALITY OF INSERTION
研究概览
简要总结
WE WILL START OUR STUDY AFTER WE GET CTRI APPROVAL. WE WANT TO COMPARE TWO SECOND GENERATION SUPRAGLOTTIC AIRWAY DEVICES IN ADULT PATIENTS BECAUSE THERE HAS BEEN MANY STUDIES DONE IN CHILDREN COMPARING I-GEL VERSUS AMBU AURAGAIN BUT VERY LESS DATA AVAILABEL FOR ADULT PATIENTS.
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
- •Elective surgeries ASA grade 1 and 2.
排除标准
- •Mouth opening less then 2.5 cm Full stomach Hiatus hernia Gatsro esophageal reflux disease cervical spine disease pharyngeal pathology laryngeal pathology.
结局指标
主要结局
QUALITY OF INSERTION
时间窗: 1) Easy or difficult insertion | 2) Number of attempts required for insertion | 3) Time taken for insertion | 4) Oropharyngeal leak pressure after 10 minutes ofinsertion | 5) Airway sealing quality score after 5 minutes of insertion
WORKING PERFORMANCE
时间窗: 1) Easy or difficult insertion | 2) Number of attempts required for insertion | 3) Time taken for insertion | 4) Oropharyngeal leak pressure after 10 minutes ofinsertion | 5) Airway sealing quality score after 5 minutes of insertion
次要结局
- PERIOPERATIVE HEMODYNAMIC PARAMETERS (PULSE RATE, SYSTOLIC BP, DIASTOLIC BP, MEAN BP, SPO2, ETCO2)(At Baseline,)
- POST OPERATIVE COMPLICATIONS(Blood stained device,)
研究者
Dr Ushma H Thakar
Smt NHL Municipal Medical College