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

Not Applicable

Completed

• Conditions: Airway Morbidity
• Interventions: Device: Prone Position; Device: Laryngeal tube; Device: Endotracheal tube Leackage

• Registration Number: NCT04158271
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief 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

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 Timeline

• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-08
• Study Start: 2019-11-22
• Status Verified: 2019-12
• Primary Completion: 2019-12-23
• Study Completion: 2019-12-23
• Last Update Submitted: 2019-12-23
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• residents and consultans of the Department of Anesthesiology

Exclusion Criteria

• no

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Evaluation of Strategies for Securing the Airway	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 Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University; 🇩🇪 Mainz, Rhineland-Palatinate, Germany