Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients

Not Applicable

Completed

Conditions: Anesthesia

Interventions: Device: Teleflex LMA Protector
Device: Ambu AuraGain
Device: Ambu aScope

Registration Number: NCT02724956

Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teleflex LMA Protector	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.
Teleflex LMA Protector	Ambu aScope	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.
Ambu AuraGain	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.
Ambu AuraGain	Ambu aScope	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.

Primary Outcome Measures

Name	Time	Method
1st Attempt Success With Supraglottic Airway Devices (SGAD)	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.

Secondary Outcome Measures

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