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

Sponsor

Johannes Gutenberg University Mainz (Other)

Overall Status

Completed

CT.gov ID

NCT04158271

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

58.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Airway Morbidity	Device: Prone Position Device: Laryngeal tube Device: Endotracheal tube Leackage	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 22, 2019

Actual Primary Completion Date :

Dec 23, 2019

Actual Study Completion Date :

Dec 23, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Time for intervention [through study completion, an average of 10 minutes]
time for Exchange the Primary airway device
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

residents and consultans of the Department of Anesthesiology

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University	Mainz	Rhineland-Palatinate	Germany	D55131

Sponsors and Collaborators

Johannes Gutenberg University Mainz

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marc Kriege, MD, Principal Investigator, Johannes Gutenberg University Mainz

ClinicalTrials.gov Identifier:

NCT04158271

Other Study ID Numbers:

JohannesGUU

First Posted:

Nov 8, 2019

Last Update Posted:

Dec 24, 2019

Last Verified:

Dec 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marc Kriege, MD, Principal Investigator, Johannes Gutenberg University Mainz

Airway Management

Tube Exchange

Study Results

No Results Posted as of Dec 24, 2019