GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management Under General Anesthesia, a Randomized Controlled Study (GLAM-I)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 498
- 试验地点
- 1
- 主要终点
- Glottic exposure grading
研究概览
简要总结
Patients were randomly assigned to three supraglottic airway devices (SADs) groups for airway management after anesthesia induced. Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed and other airway management quality was recorded.
详细描述
Mechanical ventilation was volume controlled and time cycled with tidal volumes (6-8 ml/kg) set to maintain peak inspiratory pressures of less than 20 cm H2O and ventilatory frequency adjusted to maintain end-tidal carbon dioxide (PETCO2) at 35-45 mmHg. Then a fiberoptic bronchoscope was passed through airway tube into the device to perform glottic exposure grading. Peak airway pressure, incidence of pharyngalgia, bleeding, hoarseness, and dysphagia were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators, outcome assessor and statistician were blind to the study.
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
- 否
入选标准
- •18-75 years old;
- •American Society of Anesthesiologists (ASA) I-III;
- •Body mass index (BMI)<30Kg/m2;
- •Scheduled for elective breast or lower abdominal surgery with an estimated duration of less than 4 hours;
- •Providing written inform consent.
排除标准
- •History of oropharyngeal surgery and anatomical abnormalities;
- •Limited movement of the cervical spine;
- •High risk of reflux/aspiration;
- •Emergency surgery;
- •Acute throat inflammation and upper respiratory infection;
- •History of chronic bronchitis or asthma;
- •Cognitive dysfunction and inability to communicate;
- •Participating in other clinical trials.
研究组 & 干预措施
LMA Supreme group
Patient in LMA supreme group received device of LMA supreme for airway management (one of supraglottic airway device for airway management during general anesthesia)
干预措施: LMA supreme group (Device)
I-gel group
Patient in I-gel group group received device of I-gel for airway management (one of supraglottic airway device for airway management during general anesthesia)
干预措施: I-gel group (Device)
GMA-Tulip group
Patient in GMA-Tulip group group received device of GMA-Tulip for airway management (one of supraglottic airway device for airway management during general anesthesia)
干预措施: GMA-Tulip (Device)
结局指标
主要结局
Glottic exposure grading
时间窗: From the insertion of supraglottic airway device to the end of surgery.
Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed.
次要结局
- Peak inspiratory pressures(From the insertion of supraglottic airway device to 15 minutes after insertion.)
- Plateau inspiratory pressures(From the insertion of supraglottic airway device to 15 minutes after insertion.)
- Oropharyngeal leak pressure(From the insertion of supraglottic airway device to 30 minutes after insertion)
- Oropharyngeal leak pressure at 30 and 45 degrees of head rotation(From the insertion of supraglottic airway device to 30 minutes after insertion)
- Ventilation quality(From the insertion of supraglottic airway device to 15 minutes after insertion)
- Abnormally ventilation events during surgery(From the insertion of supraglottic airway device to the end of surgery)
- Side effects at the end of surgery(From the insertion of supraglottic airway device to the patient's transfer to the ward. An average of 3 hours.)
- Side effects and adverse events 24 hours after surgery(Postoperative day 1.)
- Nasogastric tube insertion success rate(From the initial insertion to the successful placement of nasogastric tube. An average of 20 minutes.)
- Nasogastric tube insertion attempts(From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.)
- Nasogastric tube insertion time(From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.)
- Nasogastric tube insertion difficulty(From the initial supraglottic airway device insertion to the successful placement of nasogastric tube. An average of 20 minutes.)
- Reflux or aspiration risk(From the insertion of s SAD to the end of surgery. An average of 3 hours.)
- Supraglottic airway device insertion duration(From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds.)
- Supraglottic airway device insertion difficult(From the mouth open to the device seated upon encountering resistance, averaging approximately 10 seconds.)
- Supraglottic airway device insertion times(From the mouth open to the device seated upon encountering resistance or able to ventilation after device's adjustment/reinsertion, averaging approximately 10 seconds.)
研究者
Wang Jiangling
Principal Investigator
Zhejiang Cancer Hospital