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临床试验/NCT03810937
NCT03810937Unknown不适用

Optimal Head and Neck Position for Videolaryngoscopy Intubation

King Fahad Specialist Hospital Dammam2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
170
试验地点
2
主要终点
optimal head position during videolaryngoscopy intubation

研究概览

简要总结

The introduction of videolaryngoscopy constituted a revolution in airway management since it could provide better laryngeal exposure (indirect) in situations of difficult or impossible visualization by direct laryngoscopy. The use of Videolaryngoscopes, however, does not always guarantee adequate exposure or end up always in successful tracheal intubation. Failed tracheal intubation with videolaryngoscopy has been reported. We hypothesized that may be the failure was due to omitting some preparatory steps, including optimal head positioning, leading to a less than expected exposure and/or difficult or impossible intubation. There are no recommendations currently from the scientific organizations regarding the optimal head position when using a GlideScope and it is unknown currently whether head position can affect visualization or tracheal intubation attempts when using this device.

详细描述

  • Multicentric,randomized, prospective and controlled study.
  • After Institutional Review Board approval, signed written informed consents will be obtained from 165 adult patients with American Society of Anesthesiologists physical status 1-3 who are scheduled for elective surgery requiring endotracheal intubation.
  • The following parameters will assessed and documented during the preoperative airway evaluation: BMI, mouth opening, thyromental distance, range of neck movement, and modified Mallampati classification. An 8cm non-compressible pillow.
  • Patients will be randomized following coin toss into two groups depending on intubation position; Group Sniffing position(S) for obverse side and group flat position(F) for reverse side
  • After premedication, American Society of Anesthesiologists' standard monitors will be applied, and preoxygenation for 3 to 5 minutes will be performed. After anesthesia induction and complete muscle relaxation as evidenced by loss of all evoked adductor pollicis responses to train of four stimulation of the ulnar nerve:
  • Group sniffing (S): investigator will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position.
  • Group flat (F): same procedure will be done but starting from sniffing position and the patient will be intubated in flat position.
  • The laryngoscopist will be asked not to use external laryngeal manipulation and to use the same lifting force throughout the study period. If these maneuvers deemed necessary for tracheal intubation (no visualization of vocal cords from full inflation to full deflation or the reverse, the laryngoscopist will be asked grade the view before applying the maneuver then use the required maneuver and record which intervention was needed and utilized.
  • The estimated time to review theses different head elevation degrees is around 45 seconds.
  • After preoxygenation technique we have a margin of 6 to 8 minutes of apnea without significant desaturation. Investigator will exclude also patients with high risk of desaturation (obesity and initial low saturation).
  • The indirect laryngoscopic views will be graded using the same grading method used for direct laryngoscopy i.e. modified Cormack and Lehane. POGO score (percent of glottis opening viewed) will be also used to subcategorize subjects whose views lie between grade 1 and 3 C&L.

Analysis of the recorded videolaryngoscopic attempts will be performed later by a blinded researcher who was not involved with airway management.

研究设计

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

盲法说明

Analysis of the recorded videolaryngoscopic attempts will be performed later by a blinded researcher who was not involved with airway management.

入排标准

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

入选标准

  • Adult patients with American Society of Anesthesiologists physical status 1-3 who are scheduled for elective surgery requiring endotracheal intubation.

排除标准

  • history of difficult intubation, poor dentition, gastroesophageal reflux disease ,initial low oxygen saturation, severe/morbid obesity (body mass index [BMI] greater than 35 kg/m2),neck deformities, atlano-axial subluxation or at risk of aspiration.

研究组 & 干预措施

Group sniffing (S)

Active Comparator

intervention: Head position changes : we will start by performing first videolaryngoscopy to find best view in flat position then the anesthesiologist will remove the Glidescope and the patient will be positioned in sniffing position using the pillow and another videolaryngoscopy will be attempted in sniffing position to find best view in this position and the patient will be intubated in this position.

干预措施: head position (Other)

Group Flat (F)

Active Comparator

intervention: Head position changes same procedure will be done but starting from sniffing position and the patient will be intubated in flat position.

干预措施: head position (Other)

结局指标

主要结局

optimal head position during videolaryngoscopy intubation

时间窗: intratracheal intubation procedure

the optimum head position during videolaryngoscopy intubation will be successful first pass tracheal intubation.

次要结局

  • best laryngeal exposure(intratracheal intubation procedure)

研究者

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

Munir Bamadhaj

Principal Investigator

King Fahad Specialist Hospital Dammam

研究点 (2)

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