Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | November 29, 2017 |
| End Date: | November 2021 |
| Contact: | Carin A Hagberg, MD |
| Email: | CR_Study_Registration@mdanderson.org |
| Phone: | 713-563-0223 |
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.
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 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.
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.
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.
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