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

Overview

A randomized controlled study to evaluate different Techniques and Approachs for Exchange a tracheal tube or supraglottic airway device

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 18, 2019

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.

Interventions

  • Device: Prone Position
    • In a randomised order we evaluate techniques for securing the airway in paralyzed patients in prone position
  • Device: Laryngeal tube
    • In a randomised order we evaluate techniques for securing the airway in patients in with a failed laryngeal tube
  • Device: Endotracheal tube Leackage
    • In a randomised order we evaluate techniques for securing the airway in paralyzed patients with a endotracheal tube and a cuff leackage

Arms, Groups and Cohorts

  • Experimental: Prone Position
    • Evaluation of Techniques for tracheal tube Exchange in prone position
  • Experimental: Laryngeal tube
    • Evaluation of Techniques for tracheal tube Exchange in patients with laryngeal tube (LT)
  • Experimental: Endotracheal tube Leackage
    • Evaluation of Techniques for tracheal tube Exchange in critical care patients with a endotracheal tube and a high leackage

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • residents and consultans of the Department of Anesthesiology

Exclusion Criteria

  • no

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Johannes Gutenberg University Mainz
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marc Kriege, MD, Principal Investigator – Johannes Gutenberg University Mainz
  • Overall Official(s)
    • Marc Kriege, MD, Principal Investigator, University Medical Center of Johannes Gutenberg-University
  • Overall Contact(s)
    • Marc Kriege, MD, 00496131173570, makriege@uni-mainz.de

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