Evaluation of Techniques for Tracheal Tube Exchange in Standard and Critical Care Patients (TUBE)

December 23, 2019 updated by: Marc Kriege, MD, Johannes Gutenberg University Mainz
A randomized controlled study to evaluate different Techniques and Approachs for the Exchange of a tracheal tube or supraglottic airway device in a Simulator

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Exchanging a tracheal tube (ETT) in the high-risk difficult airway patient carries the risk of hypoxemia and the potential of a lost airway. Maintaining continuous airway access during the exchange by incorporating an airway exchange catheter (AEC) or similar device may reliably lessen exchange risk, especially in the known or suspected difficult airway patient, by providing a conduit to facilitate ETT passage into the trachea. We evaluated some approven / etablished techniques in a Simulator based study design.

Study Type

Interventional

Enrollment (Actual)

60

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

  • Germany
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, D55131
        • Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • residents and consultans of the Department of Anesthesiology

Exclusion Criteria:

  • no

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prone Position
Evaluation of Techniques for tracheal tube Exchange in prone position
Device: Prone Position
In a randomized order we evaluate techniques for securing the airway in paralyzed patients in prone position
Device: Laryngeal tube
In a randomized order we evaluate techniques for securing the airway in patients with a failed laryngeal tube
Device: Endotracheal tube Leackage
In a randomized order we evaluate techniques for securing the airway in paralyzed patients with a endotracheal tube and a cuff leackage
Experimental: Laryngeal tube
Evaluation of Techniques for tracheal tube Exchange in patients with laryngeal tube (LT)
Device: Prone Position
In a randomized order we evaluate techniques for securing the airway in paralyzed patients in prone position
Device: Laryngeal tube
In a randomized order we evaluate techniques for securing the airway in patients with a failed laryngeal tube
Device: Endotracheal tube Leackage
In a randomized order we evaluate techniques for securing the airway in paralyzed patients with a endotracheal tube and a cuff leackage
Experimental: Endotracheal tube Leackage
Evaluation of Techniques for tracheal tube Exchange in critical care patients with a endotracheal tube and a high leackage
Device: Prone Position
In a randomized order we evaluate techniques for securing the airway in paralyzed patients in prone position
Device: Laryngeal tube
In a randomized order we evaluate techniques for securing the airway in patients with a failed laryngeal tube
Device: Endotracheal tube Leackage
In a randomized order we evaluate techniques for securing the airway in paralyzed patients with a endotracheal tube and a cuff leackage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Strategies for Securing the Airway
Time Frame: through study completion, an average of 10 minutes
Evaluation of Strategies for securing the Airway in patients in the OR and Critical Care Medicine. Participants are confronted with three airway scenarios and perform in a Simulator different airway management strategies.
through study completion, an average of 10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for intervention
Time Frame: through study completion, an average of 10 minutes
time for Exchange the Primary airway device
through study completion, an average of 10 minutes
Anaesthesia Experience
Time Frame: through study completion, an average of 10 minutes
individual anaesthesia experience
through study completion, an average of 10 minutes
IDS
Time Frame: through study completion, an average of 10 minutes
after the Scenario we calculate the Intubation difficult score (IDS)
through study completion, an average of 10 minutes

Collaborators and Investigators

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

Sponsor

Johannes Gutenberg University Mainz

Investigators

  • Principal Investigator: Marc Kriege, MD, University Medical Center of Johannes Gutenberg-University

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 (Actual)

November 22, 2019

Primary Completion (Actual)

December 23, 2019

Study Completion (Actual)

December 23, 2019

Study Registration Dates

First Submitted

November 4, 2019

First Submitted That Met QC Criteria

November 6, 2019

First Posted (Actual)

November 8, 2019

Study Record Updates

Last Update Posted (Actual)

December 24, 2019

Last Update Submitted That Met QC Criteria

December 23, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JohannesGUU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Airway Morbidity

Clinical Trials on Prone Position

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe