CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
Ambu AuraGain +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02724956
NCT02724956N/ACompleted
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Randomized Comparison of Ambu AuraGain and Teleflex Protector Using Clinical and Fiberoptic Assessments in Elective Patients

M.D. Anderson Cancer Center·interventional·Posted Mar 31, 2016·Updated Sep 27, 2021

In Brief

A clinical study evaluating Ambu AuraGain, Teleflex LMA Protector, and 1 other intervention for Anesthesia. Completed, enrolled 53 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesUnited States
CollaboratorsAmbu A/S

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 31, 2016
Enrollment StartNov 29, 2017
Primary CompletionDec 18, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.3 years ago

Interventions

Ambu AuraGaindevice

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

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

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).