Comparison of iLTS and LMA Fastrach in a Simulated Airway.

NCT ID: NCT03542747

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2018-12-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Ventilation Therapy; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Time to ventilation with the iLTS

Intervention Type 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

Intervention Type 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

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

Group Type EXPERIMENTAL

Time to ventilation with the iLTS

Intervention Type 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

Intervention Type DEVICE

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

Interventions

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Time to ventilation with the iLTS

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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

• inability to consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Responsible Party

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Marc Kriege, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Ott, MD

Role: STUDY_DIRECTOR

Johannes GU, Mainz

Locations

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

Mainz, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 29233740 (View on PubMed)

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.

Reference Type RESULT
PMID: 26051498 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32393169 (View on PubMed)

Other Identifiers

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JohannesGUN

Identifier Type: -

Identifier Source: org_study_id

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