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临床试验/NCT04858906
NCT04858906撤回不适用

Neutral Position Facilitates Orotracheal Intubation With Videolaryngoscopes: A Comparing Angulated (McGrath) and Hyperangulated (C-MAC With D-blade) Videolaryngoscopes

Mackay Memorial Hospital0 个研究点开始时间: 2021年5月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
airway difficult score (ADS)

研究概览

简要总结

With the advent and more widespread use of video-assisted laryngoscopy (VL), the incidence of difficult intubation has decreased. However, the optimal position for endotracheal intubation facilitated by VL is not yet determined. The objective of this study is to evaluate the effects of different patient positioning (neutral position versus sniffing position) on the glottic view and intubation time during orotracheal intubation facilitated by two video-assisted laryngoscopes (McGrath laryngoscope and C-MAC D-blade laryngoscope). A total of 252 patients who required orotracheal intubation for elective surgery were included in the study. Primary outcomes include airway difficulty score(ADS), intubation difficulty scale (IDS), the percentage of glottic opening (POGO) and intubation time. By the indexes above and crossover analysis, the study aimed to prove the ideal position for VL.

详细描述

Endotracheal tube general anesthesia (ETGA) is required for a variety of surgeries. Traditionally, the patient is placed in a sniffing position to facilitate endotracheal intubation with a direct laryngoscope. Increased attempts in intubation or intubation failed may be encountered during direct laryngoscope, leading to hypoxemia or neurological sequelae. Injure to the teeth, gingiva or lips is also sometimes unavoidable. With the advent and more widespread use of video-assisted laryngoscopy (VL), the incidence of difficult intubation has decreased.

However, the optimal position for endotracheal intubation facilitated by VL is not yet determined. A previous study suggested that better glottic view is achieved when placing the patient in a neutral position than the sniffing position during orotracheal intubation by fiberoptic bronchoscopy. The objective of this study is to evaluate the effects of different patient positioning (neutral position versus sniffing position) on the glottic view and intubation time during orotracheal intubation facilitated by two video-assisted laryngoscopes (McGrath laryngoscope and C-MAC D-blade laryngoscope).

A total of 252 American Society of Anesthesiologists I-II patients, in the age above 20 years, who required orotracheal intubation for elective surgery were included in the study. Patients received nasotracheal intubation, awake tracheal intubation, emergency surgery, required rapid-sequence intubation (RSI), those in pregnancy, with possible difficult intubation(with oropharyngeal pathology, limited neck mobility, previous head and neck surgical history), anticipated difficult intubation assessed by preoperative Airway Difficult Score(ADS)(≥ 7), with allergy history of common anesthetics agents or any underlying comorbidities which refrain them from receiving common anesthetic agents were excluded.

The types of VL and the orders of position were randomly allocated by computer and the study take place in the operation room. Primary outcomes include airway difficulty (evaluated by ADS), ease of intubation (evaluated by intubation difficulty scale [IDS], the percentage of glottic opening [POGO]) and intubation time. By the indexes above and crossover analysis, the study aimed to prove the ideal position for VL, improve the efficiency of intubation and decrease the rate of difficult intubation by VL in the future.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • age above 20 years
  • Anesthesiologists I-II
  • who required orotracheal intubation for elective surgery

排除标准

  • nasotracheal intubation
  • awake tracheal intubation
  • emergency surgery
  • required rapid-sequence intubation (RSI)
  • those in pregnancy
  • with possible difficult intubation(with oropharyngeal pathology, limited neck mobility, previous head and neck surgical history)
  • anticipated difficult intubation assessed by preoperative Airway Difficult Score (≥ 7)
  • with allergy history of common anesthetics agents
  • any underlying comorbidities which refrain them from receiving common anesthetic agents

结局指标

主要结局

airway difficult score (ADS)

时间窗: Airway difficult score (ADS) is assessed before induction and it take about 3 minutes.

Airway difficult score (ADS) represents the airway difficulty and it includes thyro-mental distance, Mallampati score, mouth opening, neck mobility and upper incisions. Each element will be scored from 1 to 3 points accordingly. The higher the scores are, the more difficult the airway could be. The minimum value and the maximum value of the airway difficult score (ADS) are 5 and 15 respectively. The definition of possible difficult airway is when the airway difficult score (ADS) score is more than 7 points.

intubation difficulty scale (IDS)

时间窗: intubation difficulty scale (IDS) is assessed during intubation and the time it take depend on the difficulty of the case.

Intubation difficulty scale (IDS) represents ease of intubation and it includes times of intubation attempts, numbers of operators, grade of Modified Cormack-Lehane classification, lifting force, laryngeal pressure and vocal cord mobility. Intubation attempts, operators and grade of Modified Cormack-Lehane classification more than one will be scored directly to the numbers accordingly. The other elements will be scored from 0 to 1 point. The higher the scores are, the more difficult the intubation could be. The minimum value of the IDS is 0 and there is no limit of the maximum value. The definition of difficult intubation is when the intubation difficulty scale (IDS) score is more than 6 points.

percentage of glottic opening (POGO)

时间窗: Percentage of glottic opening (POGO) is evaluated by another anesthesiologist up to 24 hours after intubation ,and it take about 1 minutes.

Both the glottic views in first position and in second position are evaluated as percentage of glottic opening (POGO) score, ranging from 0 to 100%. The glottic views will be recorded as digital image and be evaluated by another anesthesiologist subsequently.

intubation time

时间窗: Intubation time is assessed during intubation and the time it take depend on the difficulty of the case.

Time from when the patient's mouth is opened to the time when intubation is completed and the EtCO2 is detected by the monitor will be recorded.

次要结局

  • complications(Tissue injury, sore throat and hoarseness are evaluated in the postoperative period (the day after the surgery). Desaturation or not is assessed during the procedure.)

研究者

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

Chien-Chung,Huang

Principal Investigator,Attending physician of anesthesiology

Mackay Memorial Hospital

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