跳至主要内容
临床试验/NCT06397261
NCT06397261已完成不适用

Artificial Intelligence Assisted Tracheal Video Intubation: an Observational Trial About Correctness of LarynGuide™

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Rate of correct assessment given by larynGuide™

研究概览

简要总结

This study aims to asses if the application of the larynGuide™, an assistive software running on a video-laryngoscope platform guiding laryngoscopy and intubation advise correctly and reliably on the position of the tracheal tube after an intubation attempt.

详细描述

Eligible patients will be prepared for intubation according to the local SOPs of the anesthesia departments with mandatory monitoring of SpO2, HR, NIBP, EtCO2.

For the anesthesia Patients will be pre-oxygenated before induction via face-mask with FiO2 = 1.0 and flow rates of 18L/min until etO2 reaches 90%. Induction of anesthesia and TI will be performed using a combination of sedative/hypnotic drugs, opioids and non-depolarizing muscle relaxant. The following medications will be mandatory as per protocol:

  • Hypnotic agent (Propofol 1-4 mg/kg).
  • Opioids (Fentanyl 1-3 mcg/kg, Remifentanyl 1-3 mcg/kg).
  • Non-depolarizing muscle relaxant (Rocuronium 0.5-1 mg/kg). After induction of anesthesia and the administration of the muscle relaxant, bag-mask ventilation with FiO2 = 1.0 (flow rates of 18 Lmin-1) will be performed until apnea sets in. After induction all patients will be paralyzed to facilitate airway management. Neuromuscular blockade will be assessed by train-of-four monitoring. Thereafter oxygen administration, laryngoscopy and tracheal intubation are performed as usually.

Tracheal intubation performed with the aid of larynGuide™, an assistive software running on a video-laryngoscope platform guiding laryngoscopy and intubation (aiEndoscopic, Zürich, Switzerland). The larynGuide™ will be combined with the C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with a Macintosh nr 3 or 4 blade by a board-certified anesthesiologist. The board-certified anesthesiologist performing the intubation communicates to the research staff when he completed the intubation attempt. The anaesthesiologist in charge (board certified) checks to assess the correctness of the tube position by visual check and by attaching the patient to the ventilator and measuring the endtidal CO2 (Gold standard for detection of tube placement in anesthesia).

For the study the research staff will then - after the confirmation of the anaesthesiologist in charge of the tubes correct placement - look if the software displays a green light or the words "Bad intubation" on the monitor and document either outcome.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • male or female patients ≥18 years
  • ASA class I to III
  • undergoing elective surgery in general anesthesia with tracheal intubation

排除标准

  • Contraindication for intubation with C-MAC video laryngoscope (Karl Storz, Tuttlingen, Germany) with a Macintosh nr 3 or 4 blade
  • Patients < 18 years
  • No proper trained personnel for the device at the study site
  • Expected impossible mask ventilation.
  • High risk of aspiration (requiring rapid sequence induction intubation)
  • Intracranial surgery
  • Limited knowledge of German language or refusing informed consent

结局指标

主要结局

Rate of correct assessment given by larynGuide™

时间窗: 5 minutes

Correctness of the advice measured by accuracy of the LarynGuide™, a software for artificial intelligence assisted tracheal intubation (aiEndoscopic, Zürich, Switzerland) on tube position given at the end of an intubation attempt

次要结局

  • first-attempt success rate(10 minutes)
  • Number of incidents of technical problems of larynGuide™(10 minutes)
  • Number of attempts(5 minutes)
  • Rate of Cormack & Lehane Score from 1 to 4(2 minutes)
  • Overall success rate(5 minutes)
  • Percentage of glottic opening(2 minutes)
  • Occurrence rate of airway management complications(5 minutes)

研究者

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

Thomas Riva

Prof. Dr. med. Thomas Riva

Insel Gruppe AG, University Hospital Bern

研究点 (1)

Loading locations...

相似试验