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NCT02724956

Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients

Completed NA Results posted Last updated 27 September 2021
What this trial tests

NA trial testing Ambu AuraGain in Anesthesia in 53 participants. Completed in 18 December 2020.

Timeline
29 November 2017
Primary endpoint
18 December 2020
18 December 2020

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment53
Start date29 November 2017
Primary completion18 December 2020
Estimated completion18 December 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

1st Attempt Success With Supraglottic Airway Devices (SGAD) Primary · from Anesthesia Start to Anesthesia Stop, approximately 1 hour

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.

Successful
GroupValue95% CI
Ambu AuraGain25
Teleflex LMA Protector21
Unsuccessful
GroupValue95% CI
Ambu AuraGain1
Teleflex LMA Protector3
Oropharyngeal Leak Pressure (OLP) Secondary · from Anesthesia Start to Anesthesia Stop, approximately 1 hour

OLP measured by a portable, handheld manometer.

GroupValue95% CI
Ambu AuraGain3522.00 – 68.00
Teleflex LMA Protector3715.00 – 56.20
Number of Participants With a Rate of Successful Intubation and Ventilation Secondary · from Anesthesia Start to Anesthesia Stop, approximately 1 hour

Rate of successful intubation and ventilation by utilizing the SGAD as an intubation conduit guided by the Ambu® aScope™ 3 Slim.

Successful
GroupValue95% CI
Ambu AuraGain21
Teleflex LMA Protector19
Unsuccessful
GroupValue95% CI
Ambu AuraGain5
Teleflex LMA Protector4
Number of Participants With Ease of SGAD Insertion Secondary · from Anesthesia Start to Anesthesia Stop, approximately 1 hour

Qualitative Assessment scale range of 1-4. (1) Easy; (2) Resistance, (3) Difficult; and (4) Unsuccessful.

Easy
GroupValue95% CI
Ambu AuraGain25
Teleflex LMA Protector21
Resistance
GroupValue95% CI
Ambu AuraGain1
Teleflex LMA Protector2
Difficult
GroupValue95% CI
Ambu AuraGain0
Teleflex LMA Protector0
Unsuccessful
GroupValue95% CI
Ambu AuraGain0
Teleflex LMA Protector1
Glottic Opening (POGO) Secondary · from Anesthesia Start to Anesthesia Stop, approximately 1 hour

POGO Score of 100% on First Attempt at Device Placement. All participant assessments and observations (clinical data) completed and recorded during the 1st visit

POGO- Observed
GroupValue95% CI
Ambu AuraGain26
Teleflex LMA Protector20
POGO- Not Observed
GroupValue95% CI
Ambu AuraGain0
Teleflex LMA Protector4
Functionality of Gastric Tube Placement Secondary · from Anesthesia Start to Anesthesia Stop, approximately 1 hour

Functionality of gastric drainage channel which will be inserted through the appropriate channel of the SGAD.

Easy
GroupValue95% CI
Ambu AuraGain26
Teleflex LMA Protector16
Resistance
GroupValue95% CI
Ambu AuraGain0
Teleflex LMA Protector1
Difficult
GroupValue95% CI
Ambu AuraGain0
Teleflex LMA Protector0
Unsuccessful
GroupValue95% CI
Ambu AuraGain0
Teleflex LMA Protector6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Ambu AuraGain

Trials testing the same drug.

Other recruiting trials for Anesthesia

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02724956.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing