Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients

NCT ID: NCT02724956

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-29
• Study Completion Date: 2020-12-18

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ambu AuraGain

Intervention Type: DEVICE

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.

Ambu aScope

Intervention Type: DEVICE

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).

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.

Group Type: EXPERIMENTAL

Teleflex LMA Protector

Intervention Type: DEVICE

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.

Ambu aScope

Intervention Type: DEVICE

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).

Interventions

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.

Intervention Type: 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.

Intervention Type: 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).

Intervention Type: DEVICE

Other Intervention Names

Supraglottic airway device; SGAD; LMA® Protector™; Supraglottic airway device; SGAD; LMA; laryngeal mask airway; Ambu® aScope™ 3 Slim

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ambu A/S

INDUSTRY

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carin A Hagberg, MD

Role: PRINCIPAL_INVESTIGATOR

UT MD Anderson Cancer Center

Locations

UT MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mdanderson.org

The University of Texas (UT) MD Anderson Cancer Center Official Website

Other Identifiers

HSC-MS-14-0970

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0449

Identifier Type: -

Identifier Source: org_study_id