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.
Verified date | April 2019 |
Source | Johannes Gutenberg University Mainz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparison of time to ventilation based on the chest rising of the Airway Simulator between the iLTS-D and LMA Fastrach
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University | Mainz | Rhineland-Palatinate |
Lead Sponsor | Collaborator |
---|---|
Johannes Gutenberg University Mainz |
Germany,
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
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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