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| ID | Type | Description | Link |
|---|---|---|---|
| HSC-MS-14-0970 | Other Identifier | Previous University of Texas Health Science Center ID |
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| Name | Class |
|---|---|
| Ambu A/S | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambu AuraGain | Experimental | SGAD placement using Ambu AuraGain
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|
| Teleflex LMA Protector | Experimental | SGAD placement using the Teleflex LMA Protector
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambu AuraGain | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from Anesthesia Start to Anesthesia Stop, approximately 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal Leak Pressure (OLP) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carin A Hagberg, MD | UT MD Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| The University of Texas (UT) MD Anderson Cancer Center Official Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ambu AuraGain | SGAD placement using Ambu AuraGain
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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | from Anesthesia Start to Anesthesia Stop, approximately 1 hour |
|
during the 1st visit, up to 60 minutes
no reportable AE's/SAE's for this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carin Hagberg, MD/Chief Academic Officer, CAO Office | UT MD Anderson Cancer Center | 713-792-5888 | chagberg@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2018 | Jul 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
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|
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| Teleflex LMA Protector | 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 | 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). |
|
|
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 | 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) | 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 | 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 |
| Withdrawal by Subject |
|
| BG001 | Teleflex LMA Protector | SGAD placement using the Teleflex LMA Protector
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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Supraglottic Airway (SGA) Sizes | Size 3: 30-50 kg, Size 4: 50-70 kg, and Size 5: 70-100 kg | Count of Participants | Participants |
|
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. |
|
|
| Secondary | Oropharyngeal Leak Pressure (OLP) | OLP measured by a portable, handheld manometer. | 8 participants were not recorded due to protocol deviation | Posted | Median | 95% Confidence Interval | cmH2O | from Anesthesia Start to Anesthesia Stop, approximately 1 hour |
|
|
|
| Secondary | 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. | 1 participant was not analyzed in the Teleflex LMA Protector Arm due to device failure | Posted | Count of Participants | Participants | from Anesthesia Start to Anesthesia Stop, approximately 1 hour |
|
|
|
| Secondary | Number of Participants With Ease of SGAD Insertion | Qualitative Assessment scale range of 1-4. (1) Easy; (2) Resistance, (3) Difficult; and (4) Unsuccessful. | Posted | Count of Participants | Participants | from Anesthesia Start to Anesthesia Stop, approximately 1 hour |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | from Anesthesia Start to Anesthesia Stop, approximately 1 hour |
|
|
|
| Secondary | Functionality of Gastric Tube Placement | Functionality of gastric drainage channel which will be inserted through the appropriate channel of the SGAD. | 1 participant was not analyzed in the Teleflex LMA Protector Arm due to device failure | Posted | Count of Participants | Participants | from Anesthesia Start to Anesthesia Stop, approximately 1 hour |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | 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. | 0 | 24 | 0 | 24 | 0 | 24 |
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| D008919 |
| Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| Difficult |
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| Unsuccessful |
|
| Difficult |
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| Unsuccessful |
|