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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04158271
Acronym
TUBE
Enrollment
60
Registered
2019-11-08
Start date
2019-11-22
Completion date
2019-12-23
Last updated
2019-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Morbidity

Keywords

Airway Management, Tube Exchange

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.

Interventions

DEVICEProne Position

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

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

DEVICEEndotracheal tube Leackage

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

Sponsors

Johannes Gutenberg University Mainz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* residents and consultans of the Department of Anesthesiology

Exclusion criteria

* no

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of Strategies for Securing the Airwaythrough study completion, an average of 10 minutesEvaluation 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

MeasureTime frameDescription
Time for interventionthrough study completion, an average of 10 minutestime for Exchange the Primary airway device
Anaesthesia Experiencethrough study completion, an average of 10 minutesindividual anaesthesia experience
IDSthrough study completion, an average of 10 minutesafter the Scenario we calculate the Intubation difficult score (IDS)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026