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Completed

NCT Number: NCT04158271

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

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

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Key information

Conditions

Airway Morbidity

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Mainz, Rhineland-Palatinate, D55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • residents and consultans of the Department of Anesthesiology

Exclusion criteria

  • no

Treatment and study plan

Prone Position

Device

In a randomized order we evaluate techniques for securing the airway in paralyzed patients in prone position

Laryngeal tube

Device

In a randomized order we evaluate techniques for securing the airway in patients with a failed laryngeal tube

Endotracheal tube Leackage

Device

In a randomized order we evaluate techniques for securing the airway in paralyzed patients with a endotracheal tube and a cuff leackage

Primary outcomes

  1. 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 outcomes

  1. Time for intervention

    Time frame: through study completion, an average of 10 minutes

    time for Exchange the Primary airway device

  2. Anaesthesia Experience

    Time frame: through study completion, an average of 10 minutes

    individual anaesthesia experience

  3. IDS

    Time frame: through study completion, an average of 10 minutes

    after the Scenario we calculate the Intubation difficult score (IDS)

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Acronym: TUBE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2019
Registry last updated
Dec 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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