AnesthesiaNCT02724956
Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients
A study testing Ambu AuraGain, Teleflex LMA Protector and Ambu aScope in people with Anesthesia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Ambu AuraGain, Teleflex LMA Protector and Ambu aScope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 18 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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
- Being tested
- Ambu AuraGain, Teleflex LMA Protector, Ambu aScope
- Keywords
- supraglottic airway device (SGAD) insertion, SGAD, ventilation and intubation, gastric drainage channel, fiberoptic assessment
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu AuraGainDevice
Also called Supraglottic airway device, SGAD
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.
Teleflex LMA ProtectorDevice
Also called LMA® Protector™, Supraglottic airway device, SGAD, LMA
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 aScopeDevice
Also called Ambu® aScope™ 3 Slim
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 group | Role | What they receive |
|---|---|---|
| Ambu AuraGain | Experimental | 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. Receives: Device: Ambu AuraGain; Device: Ambu aScope |
| Teleflex LMA Protector | Experimental | 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. Receives: Device: Teleflex LMA Protector; Device: Ambu aScope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Secondary outcomes (5)
Oropharyngeal Leak Pressure (OLP)
OLP measured by a portable, handheld manometer.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study start29 Nov 2017
- Primary completion18 Dec 2020
- Study completion18 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ambu A/S
- Responsible party
- Sponsor
- Investigators
- Carin A Hagberg, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724956
- Sponsor's protocol ID
- 2017-0449
- Other IDs
- HSC-MS-14-0970
- Status last verified
- Aug 2021
- First submitted
- 22 Mar 2016
- Last updated
- 27 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Ambu AuraGain and Teleflex Protector Using Clinical and Fiberoptic Assessments in Elective Patients
- ClinicalTrials.gov ID
- NCT02724956
- Acronym / sponsor ID
- 2017-0449
- Conditions
- Anesthesia
- Keywords
- supraglottic airway device (SGAD) insertion, SGAD, ventilation and intubation, gastric drainage channel, fiberoptic assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Ambu A/S
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 18 Dec 2020 (actual)
- Study completion
- 18 Dec 2020 (actual)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Posted 31 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambu AuraGain | Experimental | Device: Ambu AuraGain, Device: Ambu aScopeSGAD 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. |
| Teleflex LMA Protector | Experimental | Device: Teleflex LMA Protector, Device: Ambu aScopeSGAD 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambu AuraGainAlso: Supraglottic airway device, SGADPre-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. | Device | Ambu AuraGain |
| Teleflex LMA ProtectorAlso: LMA® Protector™, Supraglottic airway device, SGAD, LMAPre-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. | Device | Teleflex LMA Protector |
| Ambu aScopeAlso: Ambu® aScope™ 3 SlimFlexible 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). | Device | Ambu AuraGain, Teleflex LMA Protector |
Primary outcome
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.
5 secondary outcomes
Oropharyngeal Leak Pressure (OLP)
Time frame: 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
Number of Participants With Ease of SGAD Insertion
Time frame: from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Glottic Opening (POGO)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The University of Texas (UT) MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carin A Hagberg, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambu AuraGain, Teleflex LMA Protector and Ambu aScope in people with Anesthesia, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1st Attempt Success With Supraglottic Airway Devices (SGAD) (time frame: from Anesthesia Start to Anesthesia Stop, approximately 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.