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.

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

Study Overview

• Status: Completed
• Conditions: Ventilation Therapy; Complications
• Intervention / Treatment: Device: Time to ventilation with the iLTS; Device: Time to ventilation with the 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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, D55131
      • Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• inability to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Device: Time to ventilation with the Fastrach; Time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds
Experimental: 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; Time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds; Device: Time to ventilation with the Fastrach; Time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Investigators: Study Director: Thomas Ott, MD, Johannes GU, Mainz

Publications and helpful links

General Publications

• 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. No abstract available.
• 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;23:44. doi: 10.1186/s13049-015-0126-y.
• Ott T, Tschope K, Toenges G, Buggenhagen H, Engelhard K, Kriege M. Does the revised intubating laryngeal tube (ILTS-D2) perform better than the intubating laryngeal mask (Fastrach)? - a randomised simulation research study. BMC Anesthesiol. 2020 May 11;20(1):111. doi: 10.1186/s12871-020-01029-3.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): September 28, 2018
• Study Completion (Actual): December 28, 2018

Study Registration Dates

• First Submitted: May 20, 2018
• First Submitted That Met QC Criteria: May 20, 2018
• First Posted (Actual): May 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 13, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: simulation; Airway; laryngeal mask; extraglottic
• Other Study ID Numbers: JohannesGUN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No