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临床试验/NCT02188979
NCT02188979已完成不适用

GlideScope Videolaryngoscopy and Pre-Operative Assessment of El-Ganzouri Risk Index for Tracheal Intubation in Morbidly Obese Patients The Prospective Observational GLOBE Study

Università degli Studi di Brescia1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
195
试验地点
1
主要终点
Occurrence of DTI that was defined as Cormack and Lehane (C&L) grades ≥III, Intubation Difficulty Scale (IDS)>5 and modified IDS (mIDS)>5. A numeric rating scale (NRS) was also used.

研究概览

简要总结

BACKGROUND Unpredicted difficult tracheal intubation (DTI) with Macintosh laryngoscopy occurs frequently in obese patients. We investigated the incidence of DTI using the GlideScope® videolaryngoscope (GVL) with an algorithm based on a pre-operative assessment with the El Ganzouri Risk Index (EGRI).

METHODS We prospectively enrolled morbidly obese patients (BMI>40 kg/m2) undergoing abdominal surgery. Patients were scheduled for flexible fibre optic bronchoscopic intubation (FFBI) or GVL intubation if the EGRI score was ≥7 or <7, respectively. The primary outcome was the occurrence of DTI that was defined as Cormack and Lehane (C&L) grades ≥III, Intubation Difficulty Scale (IDS)>5 and modified IDS (mIDS)>5. A numeric rating scale (NRS) was also used. Secondary outcomes included intubation success during the first attempt, the time to Cormack (TTC), the time to intubation (TTI), failure to intubate, oxygen desaturation and difficult ventilation.

详细描述

The EGRI, a multivariate risk index that combines seven variables associated with DTI, was evaluated in all patients during the pre-anaesthesia visit. The results were reported in the clinical chart. All tracheal intubations in obese patients needing surgery were routinely performed using GVL. The intubations were performed or assisted by five board-certified anaesthesiologists who had prior experience with at least 20 GVL intubations, as well as at least two years of experience with anaesthesia in obese patients. In cases where the GVL intubation was performed by anaesthesiologists that were in training, the GVL expert was actively advising the operator during all of the intubating procedures. The standard equipment included a GVL with blade number three to five and an orotracheal hockey stick tube with a malleable single-use stylet (Fr 14, Intubating Stylet, DEAS). The standard anaesthesia induction started with 3-5 minutes of pre-oxygenation using 5 cm H2O PEEP in a 30° head-up position, as well as induction with fentanyl 3 μg kg -1 (LBW), propofol 2-3 mg kg -1 (LBW) and suxamethonium 1 mg Kg -1 (TBW). When spontaneous respiration ceased, the patient was mask ventilated with 100% oxygen. The tube was lubricated and advanced into the mouth under direct visual guidance to avoid complications, and then, under indirect visual guidance using the GVL monitor. The correct placement of the cuffed tube was verified using a capnograph and a stethoscope. The tube sizes were 7.0 for women and 7.5 for men. Each patient was monitored using an electrocardiogram, non-invasive arterial blood pressure measurement, and pulse oximetry before both tracheal intubation and anaesthesia induction. The basic demographic data and airway characteristics necessary to evaluate the primary outcome and to calculate the EGRI score were registered prior to anaesthesia. Patients with an EGRI score of 7 or higher were scheduled for elective fibre optic flexible bronchoscopic intubation (FFBI), while patients with an EGRI score of less than 7 underwent anaesthesia induction and GVL intubation, according to a predefined algorithm

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

  • Body Mass Index (BMI)>40 kg m-
  • Surgery with tracheal intubation scheduled

排除标准

  • age < 18 years
  • severe psychological disorders that have the possibility of limiting the patient's comprehension of information
  • previously impossible mask ventilation or intubation with GVL
  • presence of pharyngo-laryngeal or neck tumours

结局指标

主要结局

Occurrence of DTI that was defined as Cormack and Lehane (C&L) grades ≥III, Intubation Difficulty Scale (IDS)>5 and modified IDS (mIDS)>5. A numeric rating scale (NRS) was also used.

时间窗: Ten minutes after the intubation

The primary outcome was the incidence of DTI. Because scores specifically designed to assess DTI with GVL are not available, we used the Cormack and Lehane (C\&L) grades ≥III, the Intubation Difficulty Scale (IDS) \>5 and a modified IDS (mIDS) \>5 to assess DTI. We also conducted a subjective assessment of DTI as rated by the operator on a numeric rating scale (NRS), from 0 (easiest) to 10 (the most difficult procedure).

次要结局

  • intubation failures(Ten minutes after the intubation failure)
  • difficult mask ventilation(Ten minutes after the intubation)
  • oxygen desaturation(Ten minutes after the intubation)
  • frequency of tracheal intubation success during the first attempt(Ten minutes after the intubation)
  • the time to Cormack (TTC) and the time to tracheal intubation (TTI).(Ten minutes after the intubation)

研究者

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

Elena Cagnazzi

Medical Doctor Anesthesiologist

Università degli Studi di Brescia

研究点 (1)

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