Endotracheal Tube (ETT) 180: Stylet-loaded Endotracheal Tube Rotation Before Insertion to Decrease the Risk of Postoperative Sore Throat: a Randomized Double-Blind Prospective Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 357
- 试验地点
- 2
- 主要终点
- Incidence of postoperative sore throat
研究概览
简要总结
The main objective of the proposed study is to clarify whether rotating a stylet-loaded endotracheal tube (ETT) 180 degrees prior to intubation will decrease the incidence of postoperative throat soreness, when compared to standard technique used in Standard of Care.
详细描述
The researcher who is not blinded will randomize the patient to one of the three groups.
Specific technique and procedure:
- Investigators anesthesiologists assigned to perform the laryngoscopies will be limited to 6 with minimum 2 years of attending experiences to balance the variability. The results of inter-operator bias will be analyzed.
- Endotracheal Tube (ETT) size will be: 7.0 for men and women unless there will be clinical indications to use a different size of Endotracheal Tube.
- Stylet preparation: 75-degree angulation shaped preoperatively and ready for use
- Blade for either McGrath, Macintosh, or direct laryngoscopy will be size 3 for women and size 4 for men.
- Endotracheal Tube (ETT) 180: inserting endotracheal tube loaded with stylet, rotating the tube 180 degree clockwise as soon as the tube tip passes the vocal cords (glottis), and removing the stylet after the tube cuff passes through the vocal cords, which is a common practice.
- Endotracheal Tube cuff filling air pressure will be 20 cmH2O. Inflation will be made using a hand-held airway pressure manometer.
- Patient's data collection will be blinded for both patient and Investigators anesthesiologists assigned to perform the laryngoscopies
- No medications including opiates, monitoring options, and medical decisions will be altered by the study.
A member of the research team will follow-up (in person or phone-call) with each patient in the Post Anesthesia Care Unit (PACU) and 24+/- 3 hours after endotracheal tube removal to collect information regarding any symptoms of hoarseness or sore throat.
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)
盲法说明
Subjects and research personnel assessing subjects during follow-ups will be blinded throughout the study. Only the clinicians inside the operative room will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I - III
- •Ambulatory patients undergoing general anesthesia with an Endotracheal Tube (ETT) placement
- •Admitted patients undergoing general anesthesia an Endotracheal Tube (ETT) placement
- •Age > 18 and < 90 years old
- •BMI < 50
排除标准
- •Age < 18 years old or age > 90 years old
- •Pregnant women
- •Prisoners
- •Any surgery involving the pharynx, larynx, vocal cords, trachea that will create confounding factors related to postoperative sore throat
- •History of difficult airway
- •Critically ill patients requiring intensive care
研究组 & 干预措施
Direct Laryngoscopy (DL)
Standard laryngoscope use to insert the endotracheal tube and removing the stylet without any rotation.
干预措施: Direct Laryngoscope (DL) (Device)
Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuver
Standard laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.
干预措施: Direct Laryngoscope (DL) (Device)
Video laryngoscopy plus Endotracheal Tube (ETT) 180 maneuver (VLE)
Video laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.
干预措施: Endotracheal Tube (ETT) 180 (Procedure)
Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuver
Standard laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.
干预措施: Endotracheal Tube (ETT) 180 (Procedure)
Video laryngoscopy plus Endotracheal Tube (ETT) 180 maneuver (VLE)
Video laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.
干预措施: Video laryngoscope (VL) (Device)
结局指标
主要结局
Incidence of postoperative sore throat
时间窗: 24 hours after Endotracheal Tube (ETT) placement
To assess the differences in incidence of postoperative sore throat after intubation between the conventional technique and ETT 180 rotation of the ETT.
次要结局
- Incidence of hoarseness/sore throat(24 hours after Endotracheal Tube (ETT) placement)
- Severity of hoarseness/sore throat(24 hours after Endotracheal Tube (ETT) placement)
- Incidence of analgesic medication requirements to treat sore throat.(24 hours after Endotracheal Tube (ETT) placement)
研究者
Suren Soghomonyan
Assistant Professor
Ohio State University