Comparison of iLTS and LMA Fastrach in a Simulated Airway.

Not Applicable

Completed

• Conditions: Ventilation Therapy; Complications
• Interventions: Device: Time to ventilation with the iLTS; Device: Time to ventilation with the Fastrach

• Registration Number: NCT03542747
• Lead Sponsor: Johannes Gutenberg University Mainz

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-05-20
• Study First Submitted QC: 2018-05-20
• Study First Posted: 2018-05-31
• Study Start: 2018-06-01
• Primary Completion: 2018-09-28
• Study Completion: 2018-12-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-13
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

• inability to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Time to ventilation with the iLTS	Time to ventilation with the iLTS	Measuring the time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds
Time to ventilation with the iLTS	Time to ventilation with the Fastrach	Measuring the time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds
Time to ventilation with the Fastrach	Time to ventilation with the Fastrach	Measuring time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds
Time to ventilation with the Fastrach	Time to ventilation with the iLTS	Measuring time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds

Primary Outcome Measures

Name	Time	Method
Time to ventilation via endotracheal tube	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 Outcome Measures

Name	Time	Method
Time to ventilation via extraglottic airway device	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
Ease of Insertion	0 to 420 seconds	Subjective Grading of the insertion process (Lickert Scale from 1 very easy to 5 very difficult)
Intubation attempts	0 to 300 seconds	Numbers of successful intubation attempts (1-5 attempts)

Trial Locations

Locations (1)

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