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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
• inability to consent
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Ott, MD | Johannes GU, Mainz | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University | Mainz | Rhineland-Palatinate | D55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29233740 | Background | 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. | |
| 26051498 |
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| 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 |
|
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 |
| 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. |
| 32393169 | Derived | 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. |