An interventional study of Time to ventilation with the iLTS and Time to ventilation with the Fastrach in Ventilation Therapy; Complications, sponsored by Johannes Gutenberg University Mainz. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Johannes Gutenberg University Mainz · Not applicable, Interventional, and Treatment
Comparison of time to ventilation based on the chest rising of the Airway Simulator between the iLTS-D and LMA Fastrach
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.
Johannes Gutenberg University Mainz is the lead sponsor of 156 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Measuring the time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds
Device: Time to ventilation with the iLTS · Device: 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
Device: Time to ventilation with the iLTS · Device: Time to ventilation with the Fastrach
Time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds
Time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds
Time to ventilation via endotracheal tube
time to ventilation will defined from when the Endotracheal tube insert into the extraglottic airway device until the first chest rise
Time frame: 0 to 300 seconds
Time to ventilation via extraglottic airway device
time to ventilation will defined from when the device tip passed the incisors to the point until the first chest rise
Time frame: 0 to 300 seconds
Intubation attempts
Numbers of successful intubation attempts (1-5 attempts)
Time frame: 0 to 300 seconds
Ease of Insertion
Subjective Grading of the insertion process (Lickert Scale from 1 very easy to 5 very difficult)
Time frame: 0 to 420 seconds
Ran from Jun 2018 to primary completion in Sep 2018, 3 months.
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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Johannes Gutenberg University Mainz →