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临床试验/NCT05424289
NCT05424289已完成不适用

The Predictive Value of Videoryngoscopy in Preoperative Airway Evaluation in Obese Patients

Diskapi Teaching and Research Hospital1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2022年5月1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
104
试验地点
1
主要终点
Difficulty of tracheal videolaryngoscopy

研究概览

简要总结

The aim of this study is the evaluation of preoperativevideolaryngoscopy, as a possible predictor of difficult laryngoscopy and intubation during elective general anesthesia in an obese population.

Videolaryngoscopy is a minimally invasive examination performed during difficult intubation evaluation but not used routinely . On the other hand, current strategies used to predict the ease of intubation are still not sufficiently sensitive and specific. An unexpected difficult or failed intubation at the induction of general anesthesia is a seriuos, and potentially fatal, emergency in anesthesia.

In literature, a correlation between anatomical and functional parameters highlighted by videolaryngoscopy and difficulty of laryngoscopy and intubation has never been demonstrated nor indagated. There is only some case reports related evaluation of diffucult airway by videolaryngoscopy .

If proven, this might give the Anesthestiologist further information about the expected difficulty of laryngoscopy and intubation, guiding a different anesthesiological strategy.

详细描述

This is a prospective, single-center, observational study. Aim of this study is the evaluation of preoperative videolaryngoscopy as a predictor of difficult laryngoscopy and intubation during elective general anesthesia in an obese population. Unexpected difficult of failed intubation is a serious, and potentially fatal, occurrence at the induction of general anesthesia. However, current strategies used to predict the ease of intubation are still not sufficiently sensitive and specific.

Routine airway evaluation will be performed by the same anesthesiologist for patients with a BMI above 30 who will undergo general anesthesia for scheduled surgery. In the preoperative operating room, these patients will undergo videoingoscopy and a POGO score will be applied (10% lidocaine will be sprayed on tonsil sites).

The investigators who do not performed preoperative videolaryngoscopy evaluation will be also collected data about the preoperative evaluation made by the Anesthesiologist as well as the effective difficulty of laryngoscopy and intubation encountered at the induction of general anaesthesia, expressed by the Cormack - Lehane scale and the Intubation Difficulty Scale (IDS) as described in literature.

General anesthesia will be performed as usual and will not be influenced by videolaryngoscopic evaluation as the Anesthesiologist will be blind to it, and he/she will be free to choose the best anesthesiological plan for his/her patient; whether an elective awake intubation will be chosen, this will exclude the patient from the study.

For safety reasons, the only exception to blindness is an expected difficulty of intubation (POGO score 0%) by senior anesthesiologist, based upon the physician's experience. In this case, he will talk to the Anesthesiologist about and the patient will be excluded from the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Candidate to elective surgery under general anesthesia Body mass index (BMI) 30<

排除标准

  • Subjects with suspect or ascertained malignancy of the nose, mouth, phayrx, or larynx that may interfere with tracheal intubation Subjects with tracheostomy Subjects candidate to elective awake intubation

结局指标

主要结局

Difficulty of tracheal videolaryngoscopy

时间窗: Intraoperative (single assessment)

The difficulty of tracheal laryngoscopy is described with the modified Cormack - Lehane Scale.

次要结局

  • Difficulty of tracheal intubation(Intraoperative (single assessment))

研究者

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

derya özkan

Professor MD

Diskapi Teaching and Research Hospital

研究点 (1)

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