Randomized Comparison of Ambu AuraGain and Teleflex Protector Using Clinical and Fiberoptic Assessments in Elective Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- 1st Attempt Success With Supraglottic Airway Devices (SGAD)
研究概览
简要总结
Participant is being asked to take part in this study because participant is going to have surgery that requires general anesthesia (in which participant is unconscious for the procedure).
During surgery, anesthesiologists often place a supraglottic airway device (SGAD). An SGAD is a device that helps participant breathe and may help the anesthesiologist put a breathing tube in participant's airway while participant is asleep during surgery. There are many different kinds of SGADs that are readily available for use by anesthesiologists during surgery. The SGADs that are being studied are the Ambu Auragain and the Teleflex LMA Protector.
The goal of this clinical research study is to compare the effectiveness of both devices.
This is an investigational study. Both of the SGADs that are being used on this study are FDA approved and are frequently used for the surgery that participant is going to have. It is investigational to compare the 2 devices.
Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.
详细描述
Surgery:
Participant will sign a separate consent form for surgery that describes the procedure and its risks. Participant will receive anesthesia through a catheter (sterile flexible tube) in one of participant's veins. During the procedure, participant's vital signs (heart rate, blood pressure, oxygen levels) will be monitored.
Study Groups:
If participant agrees to take part in this study, demographic information (such as participant's age, sex, and race) will be collected.
Participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. Participant will have an equal (50/50) chance of being assigned to either group. One group will use the Ambu Auragain, and the other will use the Teleflex LMA Protector.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years of age or older
- •Scheduled for an elective surgery requiring general anesthesia
- •Scheduled surgery < 4hrs
- •American Society of Anesthesiology (ASA) Physical Status I-III
- •Body Mass Index (BMI) < 30 kg/m2
- •Mallampati I-III
- •Able to bite upper lip via Upper Lip Bite Test (ULBT)
- •Inter-incisor distance > 2.5cm
- •Thyromental distance > 6cm
- •Full range of motion in the neck
- •Has provided written informed consent
排除标准
- •Under the age of 18 years old
- •Require prone positioning for surgery
- •Scheduled surgery > 4hrs
- •Liquid only diet < 2hrs and/or solids < 8hrs
- •High risk of regurgitation
- •Exhibits signs of respiratory tract pathology (including a sore throat preoperatively)
- •Mallampati IV
- •Unable to bite upper lip via Upper Lip Bite Test (ULBT)
- •Inter-incisor distance < 2.5cm
- •Thyromental distance < 6cm
- •Limited neck movement
- •Airway pathology/facial abnormality
- •Has been diagnosed with/exhibits any mental neurological disorder/disease/condition that would prevent participation in the study in the opinion of the investigator.
研究组 & 干预措施
Ambu AuraGain
SGAD placement using Ambu AuraGain
- Lubricate airway tube of SGAD & pass the aScope through until visualization of the carina.
- Standard Parker Flex Tip endotracheal tube (ETT) size 6.0, 7.0, and 8.0 mm ETT will be used as per anesthesiologist preference.
- Pass ETT tube down the insertion cord of the Ambu aScope & verify placement.
- Inflate cuff and remove aScope.
干预措施: Ambu AuraGain (Device)
Ambu AuraGain
SGAD placement using Ambu AuraGain
- Lubricate airway tube of SGAD & pass the aScope through until visualization of the carina.
- Standard Parker Flex Tip endotracheal tube (ETT) size 6.0, 7.0, and 8.0 mm ETT will be used as per anesthesiologist preference.
- Pass ETT tube down the insertion cord of the Ambu aScope & verify placement.
- Inflate cuff and remove aScope.
干预措施: Ambu aScope (Device)
Teleflex LMA Protector
SGAD placement using the Teleflex LMA Protector
- Lubricate airway tube of SGAD & pass the aScope through until visualization of the carina.
- Standard Parker Flex Tip ETT size 6.0 and 7.0 mm. ETT will be used as per anesthesiologist preference.
- Pass ETT tube down the insertion cord of the Ambu aScope & verify placement.
- Inflate cuff and remove aScope.
干预措施: Teleflex LMA Protector (Device)
Teleflex LMA Protector
SGAD placement using the Teleflex LMA Protector
- Lubricate airway tube of SGAD & pass the aScope through until visualization of the carina.
- Standard Parker Flex Tip ETT size 6.0 and 7.0 mm. ETT will be used as per anesthesiologist preference.
- Pass ETT tube down the insertion cord of the Ambu aScope & verify placement.
- Inflate cuff and remove aScope.
干预措施: Ambu aScope (Device)
结局指标
主要结局
1st Attempt Success With Supraglottic Airway Devices (SGAD)
时间窗: from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Success defined as correct placement of SGAD. 1st Attempt success of SGAD either Ambu AuraGain or Teleflex LMA Protector during insertion and placement into an airway.
次要结局
- Oropharyngeal Leak Pressure (OLP)(from Anesthesia Start to Anesthesia Stop, approximately 1 hour)
- Functionality of Gastric Tube Placement(from Anesthesia Start to Anesthesia Stop, approximately 1 hour)
- Number of Participants With a Rate of Successful Intubation and Ventilation(from Anesthesia Start to Anesthesia Stop, approximately 1 hour)
- Number of Participants With Ease of SGAD Insertion(from Anesthesia Start to Anesthesia Stop, approximately 1 hour)
- Glottic Opening (POGO)(from Anesthesia Start to Anesthesia Stop, approximately 1 hour)