Prospective Comparison of Oral Intubation Via - Ambu® Aura Gain™ vs Slotted Guedel Tubus

April 11, 2019 updated by: Berthold Moser, Schulthess Klinik

Prospective Randomized Comparison Between a Flexible Fiberoptic Intubation Via the Ambu® Aura Gain™ Airway and the Slotted Guedel Tubus in Terms of Time to a Completed Airway Management and Patient Safety.

The study has to show that an intubation with the AuraGain Laryngeal mask could bring the same benefits in terms of intubation in clinical practice, as the slotted Guedel tubus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8008
        • Schulthess Klinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged ≥18
  • ASA 1 -2
  • Surgery of the shoulder, elbow, hand, hip, knee or foot
  • Signed consent form

Exclusion Criteria:

  • Patients with expected difficulties regarding to the intubation
  • Patients with diseases / anatomical changes in the area of the pharynx, the larynx, the trachea, the esophagus or the stomach
  • Not sober
  • Increased risk of aspiration
  • BMI > 35 kg/m2
  • Acute disease which could affect the suitability of the anesthesia
  • Patients in which the use of a laryngeal mask is contraindicated or otherwise not possible
  • Patients with a disease which prevents an accurate examination of the patients (eg neuromuscular, mentally, metabolic disease)
  • Drug abuse in the recent past
  • Legal incompetence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AuraGain
The patient will get a fiberoptic Intubation via the AuraGain larynxmask
Procedure: AuraGain
Fiberoptic Intubation
Placebo Comparator: Slotted Guedeltubus
The patient will get a fiberoptic intubation via the slotted Guedeltubus
Procedure: Slotted Guedeltubus
Fiberoptic Intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation time
Time Frame: Intraoperative
Time to complete the Intubation in seconds
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation attempts
Time Frame: Intraoperative
The number of intubation attempts will be recorded (eg 1, 2, 3...)
Intraoperative
Esophagal Intubation attempts
Time Frame: Intraoperative
The number of esophagal intubation attempts will be recorded (eg 1, 2, 3...)
Intraoperative
Resistance measurement of the Insertion as assessed by a four point scoring system
Time Frame: Intraoperative
1/2/3/4
Intraoperative
Position of the mask as assessed by the Brimacombe Score
Time Frame: Intraoperative
4/3/2/1
Intraoperative
Pain after Intubation as assessed by a Numeric Rating Scale
Time Frame: Intraoperative/2h postoperative/24h postoperative
mild/moderate/severe
Intraoperative/2h postoperative/24h postoperative
AE/Complications
Time Frame: Intraoperative/postoperative until 24h
Occuring AE/Complications will be recorded
Intraoperative/postoperative until 24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schulthess Klinik

Investigators

  • Principal Investigator: Berthold Moser, MD, Schulthess Klinik

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

October 6, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Schulthess_Anä_6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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