Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02724956

Enrollment

Registered

2016-03-31

Start date

2017-11-29

Completion date

2020-12-18

Last updated

2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

supraglottic airway device (SGAD) insertion, SGAD, ventilation and intubation, gastric drainage channel, fiberoptic assessment

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.

Interventions

DEVICEAmbu 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.

DEVICETeleflex 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.

DEVICEAmbu 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Oropharyngeal Leak Pressure (OLP)	from Anesthesia Start to Anesthesia Stop, approximately 1 hour	OLP measured by a portable, handheld manometer.
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
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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: 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: 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).	26
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: 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: 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).	24
Total	50

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lack of Efficacy	0	1
Overall Study	Physician Decision	1	0
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Teleflex LMA Protector	Ambu AuraGain	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	9 Participants	6 Participants	15 Participants
Age, Categorical Between 18 and 65 years	15 Participants	20 Participants	35 Participants
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment United States	24 participants	26 participants	50 participants
Sex: Female, Male Female	18 Participants	21 Participants	39 Participants
Sex: Female, Male Male	6 Participants	5 Participants	11 Participants
Supraglottic Airway (SGA) Sizes SGA Size 3	5 Participants	6 Participants	11 Participants
Supraglottic Airway (SGA) Sizes SGA Size 4	17 Participants	19 Participants	36 Participants
Supraglottic Airway (SGA) Sizes SGA Size 5	2 Participants	1 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 26	0 / 24
other Total, other adverse events	0 / 26	0 / 24
serious Total, serious adverse events	0 / 26	0 / 24

Outcome results

Primary

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.