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临床试验/CTRI/2026/03/106466
CTRI/2026/03/106466尚未招募不适用

Comparison between standard digital insertion and Macintosh direct laryngoscope guided technique of ProSeal laryngeal mask airway insertion in children: a double blind randomized study

Institute of Post Graduate Medical Education and Research and SSKM Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年5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
100
试验地点
1

研究概览

简要总结

ProSeal Laryngeal Mask Airway is commonly used for airway management during general anesthesia in children. However insertion using the standard digital blind technique may sometimes result in suboptimal positioning due to the bulky tip and soft cuff of the device. Direct visualization using a Macintosh laryngoscope may help improve placement of the device. This randomized double blind interventional study aims to compare the success rate of correct placement of ProSeal Laryngeal Mask Airway between the standard digital blind insertion technique and the Macintosh direct laryngoscope guided technique in pediatric patients undergoing elective surgery under general anesthesia. Secondary outcomes include procedure time number of insertion attempts oropharyngeal leak pressure ease of gastric tube placement and adverse events in the postoperative period. The study hypothesizes that the laryngoscope guided technique will result in a higher proportion of correct placement compared with the standard 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
2.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status 1 and 2
  • Aged between 2 to 12 years of age of either sex
  • Patients undergoing urethroplasty, orchidopexy, hernia repair, circumcision, cystoscopy with fulguration of posterior urethral valve and any other superficial abdominal surgery such as excision of umbilical granuloma, excision of sebaceous cyst or lipoma under general anaesthesia
  • Anticipated duration of surgery should be less than 2 hours.

排除标准

  • Refusal to consent
  • Known case of difficult airway
  • History of allergy to study drugs
  • Patients having cardiorespiratory disease or oropharyngeal pathology
  • Diseases related to cervical spine
  • Aspiration risk
  • If patients require ventilator support postoperatively
  • Surgery with anticipated duration of more than 2 hours will be excluded from the study.

研究者

发起方
Institute of Post Graduate Medical Education and Research and SSKM Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Harshikha Goel

Institute of Post Graduate Medical Education and Research and SSKM Hospital

研究点 (1)

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