N/A
N=53
Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT02724956 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: 1st Attempt Success With Supraglottic Airway Devices (SGAD) — 25; 21; 1; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ambu AuraGain (Device); Teleflex LMA Protector (Device); Ambu aScope (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1st Attempt Success With Supraglottic Airway Devices (SGAD) |
25; 21; 1; 3 | — |
| SECONDARY Oropharyngeal Leak Pressure (OLP) |
35; 37 | — |
| SECONDARY Number of Participants With a Rate of Successful Intubation and Ventilation |
21; 19; 5; 4 | — |
| SECONDARY Number of Participants With Ease of SGAD Insertion |
25; 21; 1; 2; 0; 0 | — |
| SECONDARY Glottic Opening (POGO) |
26; 20; 0; 4 | — |
| SECONDARY Functionality of Gastric Tube Placement |
26; 16; 0; 1; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18 years of age or older
- Scheduled for an elective surgery requiring general anesthesia
- Scheduled surgery 2.5cm
- Thyromental distance > 6cm
- Full range of motion in the neck
- Has provided written informed consent
Exclusion Criteria
- 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
- 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.
Data sourced from ClinicalTrials.gov (NCT02724956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.