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

Airway Morbidity Clinical Trial

— TUBE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04158271
• Other study ID #: JohannesGUU
• Status: Completed
• Phase: N/A
• Start date: November 22, 2019
• Est. completion date: December 23, 2019

Study information

• Verified date: December 2019
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• residents and consultans of the Department of Anesthesiology

Exclusion Criteria:

• no

Related Conditions & MeSH terms

• Airway Morbidity

Intervention

Device:
• Prone Position
In a randomized order we evaluate techniques for securing the airway in paralyzed patients in prone position
• Laryngeal tube
In a randomized order we evaluate techniques for securing the airway in patients with a failed laryngeal tube
• 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

Locations

Country	Name	City	State
Germany	Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University	Mainz	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Strategies for Securing the Airway	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	Time for intervention	time for Exchange the Primary airway device	through study completion, an average of 10 minutes
Secondary	Anaesthesia Experience	individual anaesthesia experience	through study completion, an average of 10 minutes
Secondary	IDS	after the Scenario we calculate the Intubation difficult score (IDS)	through study completion, an average of 10 minutes