NCT02492646已完成不适用
Effect of Normal Saline Lubrication of Endotracheal Tube on Post-intubation Complications: A Prospective Non-inferiority Trial
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
- 300
- 试验地点
- 1
- 主要终点
- incidence of postoperative sore throat (POST)
研究概览
简要总结
The purpose of this study is to evaluate the influence of none-lubricated dry tube on the incidence of Postoperative Sore Throat (POST) after general anesthesia with endotracheal intubation.
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)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between 20-80 years who were scheduled for surgery under general anesthesia requiring orotracheal intubation
排除标准
- •history of gastroesophageal reflux disease (GERD)
- •congenital or acquired abnormalities of the upper airway such as tumor, polyp, trauma, abscess, inflammation, infection, or foreign bodies
- •previous airway surgery; increased risk of aspiration
- •coagulation disorders
- •previous history of difficult intubation or conditions with expected difficult airway including Mallampati classification ≥ 3 or thyromental distance < 6.5 cm
- •Using the other intubation devices beyond the direct laryngoscopy such as lighted stylet or fiberoptic bronchoscopy
- •symptoms of sore throat or upper respiratory tract infection
- •expected to place nasogastric tube during perioperative period
- •requiring nasotracheal intubation
研究组 & 干预措施
Saline group
Experimental
In the saline group, disposable endotracheal tube was immersed in the 1 liter of sterile 0.9% sodium chloride irrigation solution before anesthetic induction.
干预措施: Saline group (Procedure)
Dry group
Experimental
In the dry group, endotracheal tube was peeled off from sterile packing just before orotracheal intubation.
干预措施: Dry group (Procedure)
结局指标
主要结局
incidence of postoperative sore throat (POST)
时间窗: until one day after surgery
ask patients whether they have sore throat after surgery
次要结局
- severity of postoperative sore throat (POST)(When arriving at postanesthesia care unit (PACU) and thereafter 2, 4, and 24 hours after the surgery)
- Oropharyngeal injury(2 hours and 24 hours after surgery)
- respiratory symptoms(1 week after the surgery)
研究者
Jeong-Hwa Seo
Pf.
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
Unknown
Effect of Coating of Endotracheal Tube Cuff with Local Anaesthetics in Children Undergoing SurgeryCTRI/2024/08/072234JIPMER, Puducherry
已完成
不适用
Effect of closed and open suctioning on Cardio-respiratory parametersCardio-respiratory parameters.Extremely low birth weight dysmaturity - small(ness)- fetus or newborn for gestational agep07.0, p0IRCT2013040612908N1Isfahan University of Medical Scienses44
已完成
不适用
Assessment of lung derecruitment resulting from suction of the endotracheal tube in ventilated preterm infantsVentilated preterm infantsRespiratory - Other respiratory disorders / diseasesACTRN12610000452099Judy Hough40
尚未招募
3 期
Comparison of tracheal intubation and I-GEL in gynecology laparoscopic surgery under general anesthesiaComparison of two methods of tracheal intubation and I-GEL in gynecology laparoscopic surgery under general anesthesia.Therapeutic (nonsurgical) and rehabilitative anesthesiology devices associated with adverse incidentsY70.1IRCT20170314033069N6Rasht University of Medical Sciences92
已完成
不适用
To assess the role of manipulating tracheal(wind pipe) tube cuff for negotiating gastric tube inside oesophagus(food pipe)CTRI/2022/01/039285Department of anaesthesiology and critical care Pt BDSharma PGIMS UHS Rohtak80