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临床试验/CTRI/2023/09/057881
CTRI/2023/09/057881尚未招募3 期

Comparison of Fiber-optic Assessment in Midline versus Rotatioanl Insertion Technique of Air-Q in pediatricsSurgeries;aRandomisedDouble Blind Interventional Study in Department of Anaesthesiology ,SMS Medical college and Hospital Jaipur

SMS medical college Jaipur, Rajasthan1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年9月30日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
1.Mean grading of fibre-optic bronchoscopic assessment of laryngeal view through Air-Q.

研究概览

简要总结

The anatomical difference in pediatric airway could complicate the proper placement of supraglottic airway device. The pediatric airway is different from adult in some features as they have large tongue , high larynx , lack of teeth and short neck. Therefore, it is prerequisite to assess the technique to improve positioning of Air-Q as improper position can cause laryngeal obstruction and inadequate seal. The fibre-optic bronchoscopy helps in assessing the position of Air-Q.

There are very few studies of comparison of fibre-optic bronchoscopic assessment of laryngeal view indifferent techniques of Air-Q in pediatric patient so this study is planned to compare fibre-optic bronchoscopic assessment of laryngeal view in different insertion techniques of Air-Q in pediatric surgeries.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

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

入选标准

  • A.S.A. I and II b.
  • Age range between 5 years to 12 years.
  • Weight between 10 to 30 kg d.
  • Elective inguinal, urological procedures for which SADs are routinely used.
  • Parents or caregiver willing to participate in study.

排除标准

  • a.Patient with acute upper respiratory iinfection.
  • b.Patient with difficult airway.
  • c.Surgery time more than one hrs.
  • d.Emergency surgeries.

结局指标

主要结局

1.Mean grading of fibre-optic bronchoscopic assessment of laryngeal view through Air-Q.

时间窗: mean time of insertion of AIR-Q insertion(in seconds)

2.Mean Time of Insertion

时间窗: mean time of insertion of AIR-Q insertion(in seconds)

3.Mean Score of ease of Insertion

时间窗: mean time of insertion of AIR-Q insertion(in seconds)

4.Mean Number of attempts

时间窗: mean time of insertion of AIR-Q insertion(in seconds)

次要结局

  • Mean Number of patients showing post operation complications like sore throat, cough, laryngospasm, & trauma (blood on the device after removal(1.sore throat)
  • Mean Number of patients showing post operation complications like sore throat, cough, laryngospasm, & trauma (blood on the device after removal of device)(Intraoperative Hemodynamic Monitoring)

研究者

发起方
SMS medical college Jaipur, Rajasthan
申办方类型
Government medical college

研究点 (1)

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