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临床试验/CTRI/2026/02/104352
CTRI/2026/02/104352尚未招募不适用

COMPARISON OF INTUBATING CONDITIONS WITH KINGVISION VIDEOLARYNGOSCOPE AND CONVENTIONAL LARYNGOSCOPE IN PATIENTS WITH PRE-ECLAMPSIA REQUIRING GENERAL ANAESTHESIA FOR CAESAREAN SECTION

University College of Medical Sciences1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2026年3月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
44
试验地点
1

研究概览

简要总结

Rationale Videolaryngoscopes are being widely used as first choice for tracheal intubation. Anatomic and physiologic changes during pregnancy place the parturient at increased risk for airway management problems. Obstetric patients with pre-eclampsia have already anticipated difficult airway. The predictors of difficult direct laryngoscopy are not applicable to predict a difficult videolaryngoscopy.

 TitleTo compare intubating conditions with Kingvision videolaryngoscope and conventional laryngoscope in pre-eclampsia patients requiring general anaesthesia for caesarean section.

 ObjectivesTo evaluate and compare the difficulty encountered by anaesthesiologists by Kingvision videolaryngoscopy vs conventional laryngoscopy in terms of Cormack Lehane grade laryngoscopy time tube insertion time time for successful intubation intubation difficulty score percentage of difficult intubation and success rate of intubation in the first attempt.

 Methods This prospective, randomised study will be conducted in the Department of Anaesthesiology and Critical Care, UCMS and GTBH from March 2026 to December 2026. Pre-eclampsia patients of age more than18 years and ASA physical status 2 3 with Mallampati score 2 3 scheduled for caesarean section requiring General Anaesthesia  with Tracheal Intubation will be enrolled. Patients requiring awake intubation and refusing to participate will be excluded. Patients will be randomly allocated to one of the two groups. Standard anaesthesia technique will be followed and intubation will be performed using a Kingvision videolaryngoscope  or conventional Macintosh laryngoscope depending on the group allocated.

 Sample size and Statistical analysisAccording to a previous study it has been reported that 79.6 per cent patient in whom intubation was done using Kingvision videolaryngoscope  had CL grade 1 views and 33.8 per cent patient had CL grade 1 views in Macintosh laryngoscope group in obstetric patients. To estimate the same difference using two-tailed test at alpha equal to 5 per cent and power 80 per cent minimum  sample size of  22 in each group is required.

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
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Twenty two consenting pregnant patients in each group with pre-eclampsia as diagnosed by ACOG guidelines of age more than 18 years and ASA physical status 2 and 3 scheduled for caesarean section requiring GA with tracheal intubation will be enrolled.

排除标准

  • Patient refusal patients requiring awake intubation and eclampsia.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Rashmi Salhotra

University College Of Medical Sciences

研究点 (1)

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