Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Study Procedures: After general anesthesia is given and participant falls asleep, the anesthesiologist will place the SGAD. The study staff will measure how easy it is to place the SGAD and how long each different step of the placement takes. Correct placement of the SGAD will be checked using a device with a small camera to help the doctor see participant's airway on a screen. A gastric tube will be placed to measure the volume of air and content of the stomach. Additionally the study doctor may place a breathing tube using the SGAD to make sure air is moving in and out of participant's lungs. Participant will then be positioned and prepared for the surgery. The study staff will be collecting information from the time participant enters the operating room until the time participant leaves. Additionally, participant will be interviewed after participant's surgery in the recovery room once participant is awake. Participant will be asked about any pain or soreness participant has, as well as any difficulty breathing, swallowing, or talking. This interview may take up to 5 minutes. Participation in the study will be over after the interview.

Official Title
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Randomized Comparison of Ambu AuraGain and Teleflex Protector Using Clinical and Fiberoptic Assessments in Elective Patients

Conditions
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Anesthesia

Intervention / Treatment
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* Device: Ambu AuraGain
* Device: Teleflex LMA Protector
* Device: Ambu aScope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Under the age of 18 years old ASA IV-V 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambu AuraGain<br>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. | Device: Ambu AuraGain<br>* Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.<br>* Other names: SGAD;Device: Ambu aScope<br>* Flexible scope which will be introduced into airway tube and guided through the SGAD until it will be possible to view the vocal cords. Description of the maximal optical view will be measured by the Percentage of Glottic Opening (POGO).<br>* Other names: Ambu® aScope™ 3 Slim;|
| Experimental: Teleflex LMA Protector<br>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. | Device: Teleflex LMA Protector<br>* Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.<br>* Other names: laryngeal mask airway;Device: Ambu aScope<br>* Flexible scope which will be introduced into airway tube and guided through the SGAD until it will be possible to view the vocal cords. Description of the maximal optical view will be measured by the Percentage of Glottic Opening (POGO).<br>* Other names: Ambu® aScope™ 3 Slim;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1st Attempt Success With Supraglottic Airway Devices (SGAD) | 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. | from Anesthesia Start to Anesthesia Stop, approximately 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal Leak Pressure (OLP) | OLP measured by a portable, handheld manometer. | from Anesthesia Start to Anesthesia Stop, approximately 1 hour | 
| Number of Participants With a Rate of Successful Intubation and Ventilation | Rate of successful intubation and ventilation by utilizing the SGAD as an intubation conduit guided by the Ambu® aScope™ 3 Slim. | from Anesthesia Start to Anesthesia Stop, approximately 1 hour | 
| Number of Participants With Ease of SGAD Insertion | Qualitative Assessment scale range of 1-4. (1) Easy; (2) Resistance, (3) Difficult; and (4) Unsuccessful. | from Anesthesia Start to Anesthesia Stop, approximately 1 hour | 
| Glottic Opening (POGO) | POGO Score of 100% on First Attempt at Device Placement. All participant assessments and observations (clinical data) completed and recorded during the 1st visit | from Anesthesia Start to Anesthesia Stop, approximately 1 hour | 
| Functionality of Gastric Tube Placement | Functionality of gastric drainage channel which will be inserted through the appropriate channel of the SGAD. | from Anesthesia Start to Anesthesia Stop, approximately 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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supraglottic airway device (SGAD) insertion, SGAD, ventilation and intubation, gastric drainage channel, fiberoptic assessment