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临床试验/CTRI/2025/07/091370
CTRI/2025/07/091370尚未招募不适用

Comparison of intubating conditions using ProVu™ video laryngoscope versus Macintosh laryngoscope for nasotracheal intubation- A Randomized Controlled Study

UCMS and GTB Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年8月18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
44
试验地点
1
主要终点
To compare the time to successful intubation in the two groups.

研究概览

简要总结

Although direct laryngoscopes continue to be used as the standard intubating aid, various studies have shown that video laryngoscopes offer advantages over direct laryngoscopes like a better visualization of the vocal cords and lesser time taken to intubate successfully using the latter. Studies have been done to compare the ease of intubation using video and direct laryngoscopy, but, by far, no study has been conducted to compare ProVu™ video laryngoscope with Macintosh laryngoscope in adult patients. Therefore, the present randomized single blinded control study is aimed at comparing the ease of intubation using the aforementioned laryngoscopes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Consenting ASA class 1 and 2 adults 18 to 60 years of age for elective surgeries who require nasotracheal intubation under general anaesthesia.
  • Patients with a BMI less than 30 kg per m2.

排除标准

  • Mouth opening less than 2 finger breadth.
  • Limited neck extension.
  • Patients with risk of aspiration like pregnant females, patients of abdominal trauma, intestinal obstruction, hiatus hernia, GERD and patients with a known history of delayed gastric emptying.
  • Patients with visible swelling around the neck.

结局指标

主要结局

To compare the time to successful intubation in the two groups.

时间窗: Once after intubation

次要结局

  • POGO (Percentage of Glottic Opening) score(Once after intubation)
  • Intubation difficulty score(Once after intubation)
  • Fremantle score(Once after intubation)
  • Number of attempts required to intubate(Once after intubation)
  • Hemodynamic parameters(Baseline: just before induction)
  • Trauma occurring during the intubation process(Once after intubation)
  • Additional maneuvers needed to facilitate intubation(Once after intubation)

研究者

发起方
UCMS and GTB Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ruchi Kapoor

UCMS and GTB Hospital

研究点 (1)

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