Comparison of iLTS and LMA Fastrach in a Simulated Airway.

NCT03542747 | Completed

• 1 other identifier: JohannesGUN
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ventilation Therapy; Complications

Keywords

Airway; extraglottic; simulation; laryngeal mask

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to ventilation via extraglottic airway device

  0 to 300 seconds

• Intubation attempts

  0 to 300 seconds

• Ease of Insertion

  0 to 420 seconds

Study Arms (2)

Time to ventilation with the iLTS

EXPERIMENTAL

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

Time to ventilation with the Fastrach

EXPERIMENTAL

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

Interventions

Time to ventilation with the iLTS DEVICE

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 iLTS

Time to ventilation with the Fastrach DEVICE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• inability to consent

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Mainz, Rhineland-Palatinate, D55131, Germany

Location

Related Publications (3)

• 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.

  PMID: 29233740 BACKGROUND

• 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.

  PMID: 26051498 RESULT

• 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.

  PMID: 32393169 DERIVED

Study Officials

• Thomas Ott, MD

  Johannes GU, Mainz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 20, 2018
• First Posted: May 31, 2018
• Study Start: June 1, 2018
• Primary Completion: September 28, 2018
• Study Completion: December 28, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

DE (1)