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临床试验/NCT06059248
NCT06059248已完成不适用

Effect of Different Head Positions During General Anesthesia Endotracheal Intubation on Postoperative Sore Throat

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2023年4月1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
128
试验地点
1
主要终点
Rate of Participants with postoperative sore throat

研究概览

简要总结

The goal of this [ randomized clinical trial] is to [effect of different head positions on the incidence of postoperative sore throat ] in [patients with endotracheal intubation ]. The main question it aims to answer is: the rate of postoperative sore throat will be reduced or not with the patients' head position changed during intubation.

详细描述

Objective

To investigate the effect of tracheal intubation in different head positions on the incidence of pharyngeal pain 1, 6 and 24h after operation;Effect of tracheal intubation in different head positions on the incidence of hoarseness 1, 6 and 24h after operation

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients undergoing endotracheal intubation abdominal or lower extremity surgery under general anesthesia
  • •age 18~65 years old,
  • •ASA grade I or II

排除标准

  • •patients with pre-existing sore throat or hoarseness before anesthesia;
  • •patients with cervical spine disease;
  • •patients with upper respiratory infection or a history of tracheostomy;
  • •Mallampati score ≥ 3;
  • •participation in other clinical trials within the past three months.

研究组 & 干预措施

head sniffing position group

No Intervention

The sniffing position group used the conventional method of endotracheal intubation, the operation method was the same as that of the elevation position group, after the anterior part of the tracheal tube was inserted into the glottis, the head was still kept in the backward position, and the tube core was pulled out by another anesthesiologist (the core extubation force was less than 10N), and the endotracheal tube was inserted at the same time.

head elevation position group

Experimental

The operation methods of the research group are: left hand laryngoscope, inserted into the laryngeal cavity, fully exposed glottis, right hand tracheal tube from the right corner of the mouth into the mouth, direct vision to insert the anterior part of the endotracheal tube into the glottis, and then the assistant pulls out the tube core (the strength of the extubation core is less than 10N), so that the patient's jaw is adducted, the head remains in the "elevation" position, and the endotracheal tube is inserted at the same time

干预措施: the head in the "sniffing position " (Other)

结局指标

主要结局

Rate of Participants with postoperative sore throat

时间窗: 1, 6, 24 hours after tracheal catheter removal

Postoperative sore throat is defined as: persistent sore throat with the following grades: 1 point: no sore throat; 2 points: mild, accompanied by odynophagia; 3 points: moderate pain, persistent, worsening with swallowing; 4 points: severe, pain interferes with eating, requires the use of pain medication

次要结局

  • Rate of Participants with postoperative hoarseness(1, 6, 24 hours after tracheal catheter removal)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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