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Completed

NCT Number: NCT03542747

Comparison of iLTS and LMA Fastrach in a Simulated Airway.

Comparison of time to ventilation based on the chest rising of the Airway Simulator between the iLTS-D and LMA Fastrach

Completed

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Key information

Conditions

Ventilation Therapy; Complications

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Mainz, Rhineland-Palatinate, D55131, Germany

About this study

Prior to the study every participant obtained a standardized instruction of each device. In the proposed clinical trial the primary study objective will be to determine whether there is a difference in time to ventilation via endotracheal tube (seconds) for the novel iLTS-D compared to the LMA Fastrach. Time to Ventilation will be defined from when the tip of the extraglottic airway device passed the incisors to the point until confirmation the first chest rise of the high fidelity simulator (Laerdal SimMan). Additionally, two time points before final tracheal placement will evaluated: time to place the EGA and time to ventilate with the EGA after introducing the device into the oral cavity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medical students
  • Present written informed consent of the research participant

Exclusion criteria

  • inability to consent

Treatment and study plan

Time to ventilation with the iLTS

Device

Time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds

Time to ventilation with the Fastrach

Device

Time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds

Primary outcomes

  1. Time to ventilation via endotracheal tube

    Time frame: 0 to 300 seconds

    time to ventilation will defined from when the Endotracheal tube insert into the extraglottic airway device until the first chest rise

Secondary outcomes

  1. Time to ventilation via extraglottic airway device

    Time frame: 0 to 300 seconds

    time to ventilation will defined from when the device tip passed the incisors to the point until the first chest rise

  2. Intubation attempts

    Time frame: 0 to 300 seconds

    Numbers of successful intubation attempts (1-5 attempts)

  3. Ease of Insertion

    Time frame: 0 to 420 seconds

    Subjective Grading of the insertion process (Lickert Scale from 1 very easy to 5 very difficult)

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

Comparison of the Novel iLTS and Fastrach Intubation Laryngeal Mask for Time to Ventilation in a Simulated Airway.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 31, 2018
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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