NCT05338827招募中不适用
Comparison of a Polyvinyl Chloride Tube With a Wire-reinforced Tube for Tracheal Intubation Through the SaCoVLM Video Laryngeal Mask Airway: a Randomized Controlled Study
Qianfoshan Hospital1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2022年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The total success rate of tracheal intubation
研究概览
简要总结
To compare a polyvinyl chloride tube with a wire-reinforced tube for tracheal intubation through the SaCoVLM video laryngeal mask airway, to observe the success rate of intubation and the incidence of postoperative adverse reactions, and to explore the best type of endotracheal tube through the SaCoVLM video laryngeal mask airway, so as to provide reference for its clinical application.
详细描述
- At present, there are few studies on intubation through SaCoVLM video laryngeal mask airway. It is proposed that endotracheal intubation through SaCoVLM video laryngeal mask airway is to verify its feasibility.
- The purpose is to explore the best type of endotracheal tube by observing the success rate of intubation through SaCoVLM video laryngeal mask airway and the incidence of postoperative adverse reactions.
- By observing the hemodynamic changes of the polyvinyl chloride tubes and the wire-reinforced tube during intubation through SaCoVLM video laryngeal mask airway , the effects of the two tracheal tubes on the hemodynamics of patients were compared.
- By observing the optimized operation which can improve the success rate of tracheal intubation in the experiment, it can be better applied in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to accept elective laparoscopic surgery under general anaesthesia.
- •Aged 18-70 years.
- •Body mass index (BMI) 18.5-27.9 kg/m
- •ASA class I-III.
排除标准
- •Neurological or psychiatric diseases (such as schizophrenia and depression), or unconscious.
- •Severe cardiopulmonary dysfunction.
- •Vocal cord injury, pharyngeal disease or history of neck surgery.
- •Risk of reflux aspiration and indwelling nasogastric tube before and after surgery.
- •Mouth opening less than 2 cm, limitation of cervical extension, modified Mallampati score IV.
- •SaCoVLM glottic exposure grade 3 or
- •Participated in other clinical studies during the last 3 months.
- •Refused to give informed consent for the clinical study.
结局指标
主要结局
The total success rate of tracheal intubation
时间窗: From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to half hour or 1 hour.
defined as the cumulative third-attempt intubation success rate
次要结局
- Successful insertion rate on the first attempt(From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.)
- Time of tracheal intubation(From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.)
- Site of first contact of tracheal intubation(From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.)
- Adjustment action for tracheal intubation(From the beginning of the general anaesthesia induction to tracheal intubation through an SaCO Laryngeal Mask Airway. It will take up to 15 minutes or half hour.)
- Haemodynamic fluctuation(It will take up to half hour or 1 hour.)
- Incidence of trauma as evidenced by blood(It will take up to half hour or 1 hour.)
- Incidence rate of postoperative sore throat, hoarseness and dysphagia at 24 hours after the surgery(one day after the surgery.)
研究者
Yongtao Sun
Professor
Qianfoshan Hospital
研究点 (1)
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