跳至主要内容
临床试验/CTRI/2024/03/064941
CTRI/2024/03/064941尚未招募不适用

Comparison of ultrasonography and flexible bronchoscopy for evaluation of placement of ProSeal Laryngeal Mask Airway in paediatric patients undergoing elective surgery under general anaesthesia

Vardhman Mahavir medical college and Safdarjung hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To find the agreement between Ultrasonographic and Flexible bronchoscopic evaluation of placement of ProSeal Laryngeal Mask Airway in paediatric patients undergoing elective surgery under general anaesthesia.

研究概览

简要总结

This study is intended to evaluate the feasibility of using ultrasound to evaluate the placement of a ProSeal LMA (PLMA) compared to the gold standard bronchoscopy. Children aged 3 to 12 years planned for elective surgery in supine position under general anaesthesia with ProSeal LMA placement will be selected for this study. Inj Fentanyl (2 mcg/kg) + Inj Propofol (2 mg/kg) will be given for induction. Inj Vecuronium (0.1 mcg/kg) will be given for facilitating PLMA placement. PLMA of appropriate size (according to weight based criteria) will be inserted. Placement of PLMA will be confirmed using clinical parameters (Visible bilateral chest rise , bilateral equal air entry on auscultation, SPO2 > 95%, successful insertion of gastric tube, capnogram). Patients with ‘Clinically acceptable’ placed PLMA will be selected for this study. In these patients USG will be done followed by flexible bronchoscopy. Ultrasonographic evaluation of placement of PLMA will be done in 3 planes and scoring will be done. Flexible bronchoscopic evaluation of placement of PLMA and Brimacombe grading will be done.  After completion of surgery, neuromuscular blockade reversal will be given and trachea will be extubated. Patient will be observed in PACU for 2 hours. This study aims to correlate the number of USG-acceptable PLMA placements with number of flexible bronchoscope confirmed correct PLMA placements.

研究设计

研究类型
Observational

入排标准

年龄范围
3.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Paediatric patients aged 3 to 12 years belonging to American Society of Anesthesiologists ASA grade I and II scheduled for elective surgery in supine position under general anaesthesia requiring ProSeal LMA placement as an airway device.

排除标准

  • Anticipated difficult airway Children at increased risk of aspiration Obese children with BMI more than 30.

结局指标

主要结局

To find the agreement between Ultrasonographic and Flexible bronchoscopic evaluation of placement of ProSeal Laryngeal Mask Airway in paediatric patients undergoing elective surgery under general anaesthesia.

时间窗: Baseline, after induction, immediately after LMA insertion, 5 minutes after LMA insertion, 10 minutes after LMA insertion

次要结局

  • To compare the time taken to evaluate the placement of ProSeal Laryngeal Mask Airway in paediatric patients by Ultrasonography & Flexible bronchoscopy(Baseline)

研究者

发起方
Vardhman Mahavir medical college and Safdarjung hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

KIRANJOT KAUR

Vardhman Mahavir Medical College and Safdarjung hospital

研究点 (1)

Loading locations...

相似试验