NCT04158271

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

November 22, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
Last Updated

December 24, 2019

Status Verified

December 1, 2019

Enrollment Period

1 month

First QC Date

November 4, 2019

Last Update Submit

December 23, 2019

Conditions

Keywords

Airway ManagementTube Exchange

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Time for intervention

    through study completion, an average of 10 minutes

  • Anaesthesia Experience

    through study completion, an average of 10 minutes

  • IDS

    through study completion, an average of 10 minutes

Study Arms (3)

Prone Position

EXPERIMENTAL

Evaluation of Techniques for tracheal tube Exchange in prone position

Device: Prone PositionDevice: Laryngeal tubeDevice: Endotracheal tube Leackage

Laryngeal tube

EXPERIMENTAL

Evaluation of Techniques for tracheal tube Exchange in patients with laryngeal tube (LT)

Device: Prone PositionDevice: Laryngeal tubeDevice: Endotracheal tube Leackage

Endotracheal tube Leackage

EXPERIMENTAL

Evaluation of Techniques for tracheal tube Exchange in critical care patients with a endotracheal tube and a high leackage

Device: Prone PositionDevice: Laryngeal tubeDevice: Endotracheal tube Leackage

Interventions

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

Endotracheal tube LeackageLaryngeal tubeProne Position

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

Endotracheal tube LeackageLaryngeal tubeProne Position

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

Endotracheal tube LeackageLaryngeal tubeProne Position

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • residents and consultans of the Department of Anesthesiology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mainz, Rhineland-Palatinate, D55131, Germany

Location

Study Officials

  • Marc Kriege, MD

    University Medical Center of Johannes Gutenberg-University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 8, 2019

Study Start

November 22, 2019

Primary Completion

December 23, 2019

Study Completion

December 23, 2019

Last Updated

December 24, 2019

Record last verified: 2019-12

Locations