Clinical trial NCT02724956: Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients
Official title: Randomized Comparison of Ambu AuraGain and Teleflex Protector Using Clinical and Fiberoptic Assessments in Elective Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: supraglottic airway device (SGAD) insertion
SGAD
ventilation and intubation
gastric drainage channel
fiberoptic assessment
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Ambu A/S
First posted: 2016-03-31
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 1st Attempt Success With Supraglottic Airway Devices (SGAD)
timeFrame: from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Secondary outcomes:
measure: Oropharyngeal Leak Pressure (OLP)
timeFrame: from Anesthesia Start to Anesthesia Stop, approximately 1 hour
measure: Number of Participants With a Rate of Successful Intubation and Ventilation
timeFrame: from Anesthesia Start to Anesthesia Stop, approximately 1 hour
measure: Number of Participants With Ease of SGAD Insertion
timeFrame: from Anesthesia Start to Anesthesia Stop, approximately 1 hour
measure: Glottic Opening (POGO)
timeFrame: from Anesthesia Start to Anesthesia Stop, approximately 1 hour
measure: Functionality of Gastric Tube Placement
timeFrame: from Anesthesia Start to Anesthesia Stop, approximately 1 hour
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: UT MD Anderson Cancer Center
name: Carin A Hagberg, MD
role: PRINCIPAL_INVESTIGATOR
References: