Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients

August 30, 2021 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 years of age or older
  2. Scheduled for an elective surgery requiring general anesthesia
  3. Scheduled surgery < 4hrs
  4. American Society of Anesthesiology (ASA) Physical Status I-III
  5. Body Mass Index (BMI) < 30 kg/m2
  6. Mallampati I-III
  7. Able to bite upper lip via Upper Lip Bite Test (ULBT)
  8. Inter-incisor distance > 2.5cm
  9. Thyromental distance > 6cm
  10. Full range of motion in the neck
  11. Has provided written informed consent

Exclusion Criteria:

  1. Under the age of 18 years old
  2. ASA IV-V
  3. Require prone positioning for surgery
  4. Scheduled surgery > 4hrs
  5. Liquid only diet < 2hrs and/or solids < 8hrs
  6. High risk of regurgitation
  7. Exhibits signs of respiratory tract pathology (including a sore throat preoperatively)
  8. Mallampati IV
  9. Unable to bite upper lip via Upper Lip Bite Test (ULBT)
  10. Inter-incisor distance < 2.5cm
  11. Thyromental distance < 6cm
  12. Limited neck movement
  13. Airway pathology/facial abnormality
  14. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Ambu AuraGain
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.
Other Names:
  • Supraglottic airway device
  • SGAD
Device: Ambu aScope
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).
Other Names:
  • Ambu® aScope™ 3 Slim
Experimental: 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.
Device: Ambu aScope
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).
Other Names:
  • Ambu® aScope™ 3 Slim
Device: Teleflex LMA Protector
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.
Other Names:
  • LMA
  • laryngeal mask airway
  • Supraglottic airway device
  • SGAD
  • LMA® Protector™

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oropharyngeal Leak Pressure (OLP)
Time Frame: from Anesthesia Start to Anesthesia Stop, approximately 1 hour
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
Time Frame: 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.
from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Number of Participants With Ease of SGAD Insertion
Time Frame: 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.
from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Glottic Opening (POGO)
Time Frame: 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
from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Functionality of Gastric Tube Placement
Time Frame: 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.
from Anesthesia Start to Anesthesia Stop, approximately 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Ambu A/S

Investigators

  • Principal Investigator: Carin A Hagberg, MD, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2017

Primary Completion (Actual)

December 18, 2020

Study Completion (Actual)

December 18, 2020

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

March 25, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-0449
  • HSC-MS-14-0970 (Other Identifier: Previous University of Texas Health Science Center ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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