Comparison of iLTS and LMA Fastrach in a Simulated Airway.

Ventilation Therapy; Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542747
• Other study ID #: JohannesGUN
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 28, 2018

Study information

• Verified date: April 2019
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 28, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Medical students

• Present written informed consent of the research participant

Exclusion Criteria:

• inability to consent

Related Conditions & MeSH terms

• Ventilation Therapy; Complications

Intervention

Device:
• Time to ventilation with the iLTS
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 (ET) based of insert the Fastrach until the chest rise of the simulator in seconds

Locations

Country	Name	City	State
Germany	Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University	Mainz	Rhineland-Palatinate

Sponsors (1)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Ott T, Fischer M, Limbach T, Schmidtmann I, Piepho T, Noppens RR. The novel intubating laryngeal tube (iLTS-D) is comparable to the intubating laryngeal mask (Fastrach) - a prospective randomised manikin study. Scand J Trauma Resusc Emerg Med. 2015 Jun 8; — View Citation

Perkins GD, Olasveengen TM, Maconochie I, Soar J, Wyllie J, Greif R, Lockey A, Semeraro F, Van de Voorde P, Lott C, Monsieurs KG, Nolan JP; European Resuscitation Council. European Resuscitation Council Guidelines for Resuscitation: 2017 update. Resuscitation. 2018 Feb;123:43-50. doi: 10.1016/j.resuscitation.2017.12.007. Epub 2017 Dec 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	0 to 300 seconds
Secondary	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	0 to 300 seconds
Secondary	Intubation attempts	Numbers of successful intubation attempts (1-5 attempts)	0 to 300 seconds
Secondary	Ease of Insertion	Subjective Grading of the insertion process (Lickert Scale from 1 very easy to 5 very difficult)	0 to 420 seconds