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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03542747
Other study ID # JohannesGUN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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