CTRI/2025/09/095465尚未招募Post Marketing Surveillance
Comparison of Supraglottic assisted fiberoptic intubation (SAFI) with video assisted fiberoptic intubation (VAFI) in children requiring endotracheal intubation for elective surgery among trainees: SAVIO Trial
试验速览
- 阶段
- Post Marketing Surveillance
- 状态
- 尚未招募
- 发起方
- PGIMER
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The time taken to perform tracheal intubation
研究概览
简要总结
Children in the age group of 1 month to 2 years undergoing surgery would be enrolled. They would be divided into 2 groups undergoing fiberoptic intubation using either supraglottic airway or a videolaryngoscope. Time take to intubate would be recorded as the primary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Month(s) 至 2.00 Year(s)（—）
- 性别
- All
入选标准
- •Paediatric patients of ASA status I and II in the age range of 1month -2 years of either gender Requiring endotracheal intubation for undergoing elective surgery.
排除标准
- •Patient’s parental Refusal Anticipated Difficult Airway Tonsillar/adenoid hyperplasia Congenital airway anomalies Coagulation defects History of a recent upper respiratory tract infection or significant pulmonary disease • Children requiring RSI (Full stomach, Active GERD) • Severe Obstructive sleep apnea • ASA Physical status 3 or higher.
结局指标
主要结局
The time taken to perform tracheal intubation
时间窗: 1 second after intubation
次要结局
- First pass success rate(30 seconds At the end of intubation)
- glottic visualization using Cormack & Lehane glottic score (CL)(30 seconds after laryngoscopy)
- intubation difficulty score(30 seconds after intubation)
- Complications(1 hour after the end of surgery)
研究者
Divya Jain
Postgraduate Institute of medical education and research
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
In paediatric population, 2 types of supraglottic airway devices will be used - Igel and Classic laryngeal airway and their ease of insertion and variation in vitals of the patient will be compared.CTRI/2025/03/083001Christian Medical College and Hospital70
尚未招募
Phase 3 4
A study comparing camera guided and regular methods of placing a breathing device inside mouth in children before surgeryCTRI/2025/11/098178RAKHI V P46
尚未招募
2 期
Comparison of 2 supraglottic airway devices,Ambu AuraGain Vs BlockBuster Laryngeal Mask, in laproscopic surgeries in childrenCTRI/2025/05/087184SMs Medical College and Attached Hospitals64
尚未招募
不适用
Evaluation of SaCo VLMA for General Anesthesia for Laparoscopic ProceduresNCT07391969Medical University of Lodz20
尚未招募
不适用
A comparison of two airway management devices i.e. GMA-Tulip and i-gel in adult patients undergoing general anaesthesiaCTRI/2025/11/097430100