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Comparison of iLTS and LMA Fastrach in a Simulated Airway.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03542747
Enrollment
160
Registered
2018-05-31
Start date
2018-06-01
Completion date
2018-12-28
Last updated
2019-04-16

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

Conditions

Ventilation Therapy; Complications

Keywords

Airway, extraglottic, simulation, laryngeal mask

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.

Interventions

DEVICETime to ventilation with the iLTS

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

DEVICETime to ventilation with the Fastrach

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

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
No

Inclusion criteria

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

Exclusion criteria

• inability to consent

Design outcomes

Primary

MeasureTime frameDescription
Time to ventilation via endotracheal tube0 to 300 secondstime to ventilation will defined from when the Endotracheal tube insert into the extraglottic airway device until the first chest rise

Secondary

MeasureTime frameDescription
Time to ventilation via extraglottic airway device0 to 300 secondstime to ventilation will defined from when the device tip passed the incisors to the point until the first chest rise
Intubation attempts0 to 300 secondsNumbers of successful intubation attempts (1-5 attempts)
Ease of Insertion0 to 420 secondsSubjective Grading of the insertion process (Lickert Scale from 1 very easy to 5 very difficult)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026