跳至主要内容
临床试验/NCT03357679
NCT03357679已完成不适用

Comparison of Bed up Head Elevated Intubation Position With Glidescope Assisted Tracheal Intubation: A Randomised, Controlled, Non-inferiority Trial

University of Malaya2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2017年12月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
138
试验地点
2
主要终点
Time required for intubation

研究概览

简要总结

Positioning during the process of tracheal intubation is critical, as optimal positioning can greatly facilitate successful intubation. Many complications can occur as a result of failed intubation, ranging from airway injury, lack of oxygen, with even deaths. Today, the most popular positioning of patients for intubation is in the "sniffing" position. There is however evidence to support that intubation in the bed-up-head-elevated position may be better. In today's technological age, video assisted laryngoscopy (Laryngoscopy is the process of visualizing the vocal cords prior to intubation), a new method where the anaesthetist intubates a patient via aid of an image guided view of the airway, is increasingly popular due to its reliability and superiority to normal intubation. However, it is not widely available, and may suffer from technical breakdowns. The Glidescope is one example of a video laryngoscope, and has been widely researched in the medical literature. In this study, the investigators wish to investigate whether intubation in the bed-up-head-elevated position will be as good as, if not better than Glidescope assisted tracheal intubation, in patients undergoing elective surgery and planned for general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

盲法说明

Investigator is blinded to the initial laryngeal exposure during the sniffing position, but is unblinded during assessment of laryngeal exposure in either the bed up head elevated position or glidescope assisted tracheal intubation

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

  • Patients undergoing elective surgeries under general anaesthesia
  • Patients aged from 18 years old to 75 years old
  • Patients who are able to give informed consent

排除标准

  • Patients with airway obstruction
  • Patients with contraindications to neck extension
  • Patients with small mouth opening (<3 cm)
  • BMI > 35 kg/m3
  • Patients with ischemic heart disease, cerebrovascular disease and respiratory diseases
  • Patients in whom rapid sequence induction is indicated

研究组 & 干预措施

Bed up head elevated intubation

Active Comparator

Patients positioned in the bed up head elevated position, followed by tracheal intubation

干预措施: Tracheal intubation (Procedure)

Bed up head elevated intubation

Active Comparator

Patients positioned in the bed up head elevated position, followed by tracheal intubation

干预措施: Bed up head elevated tracheal intubation (Device)

Glidescope assisted intubation

Active Comparator

Glidescope is used for laryngoscopy, followed by intubation

干预措施: Tracheal intubation (Procedure)

Glidescope assisted intubation

Active Comparator

Glidescope is used for laryngoscopy, followed by intubation

干预措施: Glidescope assisted tracheal intubation (Device)

结局指标

主要结局

Time required for intubation

时间窗: Through study completion, period of 1 year

Measured from the time the tip of the laryngoscope passes through the incisors to the time of the first recorded wave of capnography

Laryngeal exposure

时间窗: Through study completion, period of 1 year

Measured by Percentage of Glottic Opening (POGO) score. A 100% POGO score refers to visualisation of the entire glottic opening from the anterior commissure of the vocal cords to the interarytenoid notch. A POGO score of 0% refers to no visualisation of laryngeal structures. A 100% score is optimal.

次要结局

  • Number of intubation attempts(Through study completion, period of 1 year)
  • Effort during laryngoscopy(Through study completion, period of 1 year)
  • Airway trauma(Through study completion, period of 1 year)
  • Complications arising from intubation(Through study completion, period of 1 year)

研究者

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

Samuel E H Tsan, MD, BMedSc

Doctor

University of Malaya

研究点 (2)

Loading locations...

相似试验