Ambu AuraGain and Teleflex LMA Protector Fiberoptic Assessments in Elective Patients

NCT02724956 | Completed Results FDA Device

• 2 other identifiers: 2017-0449HSC-MS-14-0970
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

supraglottic airway device (SGAD) insertion; SGAD; ventilation and intubation; gastric drainage channel; fiberoptic assessment

Outcome Measures

Primary Outcomes (1)

• 1st Attempt Success With Supraglottic Airway Devices (SGAD)

  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.

  from Anesthesia Start to Anesthesia Stop, approximately 1 hour

Secondary Outcomes (5)

• Oropharyngeal Leak Pressure (OLP)

  from Anesthesia Start to Anesthesia Stop, approximately 1 hour

• Number of Participants With a Rate of Successful Intubation and Ventilation

  from Anesthesia Start to Anesthesia Stop, approximately 1 hour

• Number of Participants With Ease of SGAD Insertion

  from Anesthesia Start to Anesthesia Stop, approximately 1 hour

• Glottic Opening (POGO)

  from Anesthesia Start to Anesthesia Stop, approximately 1 hour

• Functionality of Gastric Tube Placement

  from Anesthesia Start to Anesthesia Stop, approximately 1 hour

Study Arms (2)

Ambu AuraGain

EXPERIMENTAL

SGAD placement using Ambu AuraGain * Lubricate airway tube of SGAD \& pass the aScope through until visualization of the carina. * Standard Parker Flex Tip endotracheal tube (ETT) size 6.0, 7.0, and 8.0 mm ETT will be used as per anesthesiologist preference. * Pass ETT tube down the insertion cord of the Ambu aScope \& verify placement. * Inflate cuff and remove aScope.

Device: Ambu AuraGain; Device: Ambu aScope

Teleflex LMA Protector

EXPERIMENTAL

SGAD placement using the Teleflex LMA Protector * Lubricate airway tube of SGAD \& pass the aScope through until visualization of the carina. * Standard Parker Flex Tip ETT size 6.0 and 7.0 mm. ETT will be used as per anesthesiologist preference. * Pass ETT tube down the insertion cord of the Ambu aScope \& verify placement. * Inflate cuff and remove aScope.

Device: Teleflex LMA Protector; Device: Ambu aScope

Interventions

Ambu AuraGain DEVICE

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.

Also known as: Supraglottic airway device, SGAD

Ambu AuraGain

Teleflex LMA Protector DEVICE

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.

Also known as: LMA® Protector™, Supraglottic airway device, SGAD, LMA, laryngeal mask airway

Teleflex LMA Protector

Ambu aScope DEVICE

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).

Also known as: Ambu® aScope™ 3 Slim

Ambu AuraGain; Teleflex LMA Protector

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years of age or older
• Scheduled for an elective surgery requiring general anesthesia
• Scheduled surgery \< 4hrs
• American Society of Anesthesiology (ASA) Physical Status I-III
• Body Mass Index (BMI) \< 30 kg/m2
• Mallampati I-III
• Able to bite upper lip via Upper Lip Bite Test (ULBT)
• Inter-incisor distance \> 2.5cm
• Thyromental distance \> 6cm
• Full range of motion in the neck
• Has provided written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Ambu A/S: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas (UT) MD Anderson Cancer Center Official Website

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Laryngeal Masks

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Carin Hagberg, MD/Chief Academic Officer, CAO Office
• Organization: UT MD Anderson Cancer Center

chagberg@mdanderson.org

713-792-5888

Study Officials

• Carin A Hagberg, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: March 31, 2016
• Study Start: November 29, 2017
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: September 27, 2021
• Results First Posted: August 31, 2021

Record last verified: 2021-08

Locations

US (1)