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临床试验/NCT06622538
NCT06622538已完成不适用

Orotracheal Intubation with the ORION Videolaryngoscope Versus the King Vision Videolaryngoscope in Adult Patients Without Predictors of a Difficult Airway

Hospital General de México Dr. Eduardo Liceaga1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Successful first attempt

研究概览

简要总结

This study aims to compare the ORION video laryngoscope with the King Vision video laryngoscope for orotracheal intubation in patients without predictors of difficult airway scheduled for elective surgery under general anesthesia.

详细描述

The video laryngoscope, compared to direct laryngoscopy, provides better visualization of the laryngeal and glottic structures, a higher success rate for intubation on the first attempt, and a lower incidence of complications such as mucosal injury, dental injury, and esophageal intubations. Despite the advantages offered by video laryngoscopy, its use is not widespread in developing countries due to high costs. For this reason, the ORION video laryngoscope was developed as a low-cost, reusable device that can undergo high-level disinfection. It is designed using additive manufacturing and meets the standards for biocompatibility, rigidity, and resistance. Additionally, it has undergone preclinical testing in simulation models where anesthesiologists have approved its use in real clinical scenarios. In this study, patients scheduled for elective surgery under general anesthesia without predictors of difficult airway will be included and randomized to be intubated with either the ORION video laryngoscope or the King Vision video laryngoscope. The study will compare the success of intubation on the first attempt, the time taken for intubation, the level of visualization of the glottic structures, and the associated complications between the two video laryngoscopes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients over 18 years of age scheduled for elective surgery requiring general anesthesia.
  • •Patients without predictors of difficult airway.
  • •Patients with ASA I-II classification.
  • •Patients with BMI less than 35 kg/mts2.

排除标准

  • •Pregnant women.
  • •Patients requiring emergency surgery.
  • •Patients with chronic obstructive pulmonary disease.
  • •Patients with a history of chronic ischemic heart disease.
  • •Patients with a history of asthma.
  • •Patients who have not signed the informed consent to participate in the study.

研究组 & 干预措施

Videolaryngoscope King Vision

Active Comparator

The King Vision video laryngoscope used in this study has a 45° angulation, with a disposable No. 3 blade and no channel for the orotracheal tube.

干预措施: Orotracheal intubation (Device)

Videolaryngoscope ORION

Experimental

The ORION video laryngoscope is designed by additive manufacturing, has the same dimensions as a Macintosh No. 3 blade, with 45° angulation, is biocompatible and reusable when subjected to high-level disinfection with 2% Glutaraldehyde for 40 minutes. It has an endoscopic camera fully covered in the body of the videolaryngoscope of 8 mm diameter with 2 megapixels with a resolution of 1280x720, has a viewing angle of 70°, has 6 LEDS with adjustable intensity and the camera has an anti-fogging system and can be connected to any mobile device with Android operating system through a free application. (AN98 Version 2.2.0). It complies with ISO 7376:2020 standards for orotracheal intubation laryngoscopes because its blade withstands a stiffness of more than 60 Newtons and a resistance of more than 150 Newtons.

干预措施: Orotracheal intubation (Device)

结局指标

主要结局

Successful first attempt

时间窗: After the endotracheal intubation completed

Measurement of orotracheal intubations obtained in the first attempt of videolaryngoscopy with the two videolaryngoscopes, successful orotracheal intubation will be corroborated by capnography. Measured in percentage (%).

次要结局

  • Laryngeal visualisation measured with the POGO scale(After the endotracheal intubation completed)
  • Esophageal intubation(After the endotracheal intubation completed)
  • Intubation time(After the endotracheal intubation completed)
  • Laryngeal visualisation measured with the Cormack Lehane scale(After the endotracheal intubation completed)
  • Complications(After the endotracheal intubation completed)
  • Intubation failure(After the endotracheal intubation completed)
  • Number of video laryngoscopy attempts(After the endotracheal intubation completed)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Juan Fernando Bautista Garcia

M.D.

Hospital General de México Dr. Eduardo Liceaga

研究点 (1)

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