An interventional study of Ambu AuraGain and Teleflex LMA Protector in Anesthesia, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-27.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Supportive care
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.
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.
M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Device: 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.
Device: Teleflex LMA Protector · Device: Ambu aScope
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.
Also known as: Supraglottic airway device, SGAD
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.
Also known as: LMA® Protector™, Supraglottic airway device, SGAD, LMA, laryngeal mask airway
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).
Also known as: Ambu® aScope™ 3 Slim
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.
Time frame: from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Oropharyngeal Leak Pressure (OLP)
OLP measured by a portable, handheld manometer.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: from Anesthesia Start to Anesthesia Stop, approximately 1 hour
| Milestone | Ambu AuraGain | Teleflex LMA Protector |
|---|---|---|
| Started | 27 | 26 |
| Completed | 26 | 24 |
| Not completed | 1 | 2 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| Participants | Ambu AuraGain | Teleflex LMA Protector |
|---|---|---|
| Successful | 25 | 21 |
| Unsuccessful | 1 | 3 |
OLP measured by a portable, handheld manometer.
| cmH2O | Ambu AuraGain | Teleflex LMA Protector |
|---|---|---|
| Oropharyngeal Leak Pressure (OLP) | 35 (22.00 to 68.00) | 37 (15.00 to 56.20) |
Rate of successful intubation and ventilation by utilizing the SGAD as an intubation conduit guided by the Ambu® aScope™ 3 Slim.
| Participants | Ambu AuraGain | Teleflex LMA Protector |
|---|---|---|
| Successful | 21 | 19 |
| Unsuccessful | 5 | 4 |
Qualitative Assessment scale range of 1-4. (1) Easy; (2) Resistance, (3) Difficult; and (4) Unsuccessful.
| Participants | Ambu AuraGain | Teleflex LMA Protector |
|---|---|---|
| Easy | 25 | 21 |
| Resistance | 1 | 2 |
| Difficult | 0 | 0 |
| Unsuccessful | 0 | 1 |
POGO Score of 100% on First Attempt at Device Placement. All participant assessments and observations (clinical data) completed and recorded during the 1st visit
| Participants | Ambu AuraGain | Teleflex LMA Protector |
|---|---|---|
| POGO- Observed | 26 | 20 |
| POGO- Not Observed | 0 | 4 |
Functionality of gastric drainage channel which will be inserted through the appropriate channel of the SGAD.
| Participants | Ambu AuraGain | Teleflex LMA Protector |
|---|---|---|
| Easy | 26 | 16 |
| Resistance | 0 | 1 |
| Difficult | 0 | 0 |
| Unsuccessful | 0 | 6 |
Collected over during the 1st visit, up to 60 minutes. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ambu AuraGain | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Teleflex LMA Protector | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Categorical(Participants) | Ambu AuraGain | Teleflex LMA Protector | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 15 | 35 |
| >=65 years | 6 | 9 | 15 |
| Sex: Female, Male(Participants) | Ambu AuraGain | Teleflex LMA Protector | Total |
|---|---|---|---|
| Female | 21 | 18 | 39 |
| Male | 5 | 6 | 11 |
| Race and Ethnicity Not Collected(Participants) | Ambu AuraGain | Teleflex LMA Protector | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Ambu AuraGain | Teleflex LMA Protector | Total |
|---|---|---|---|
| United States | 26 | 24 | 50 |
| Supraglottic Airway (SGA) Sizes(Participants) | Ambu AuraGain | Teleflex LMA Protector | Total |
|---|---|---|---|
| SGA Size 3 | 6 | 5 | 11 |
| SGA Size 4 | 19 | 17 | 36 |
| SGA Size 5 | 1 | 2 | 3 |
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M.D. Anderson Cancer Center