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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03848559
Other study ID # AirMicroMod
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date May 30, 2020

Study information

Verified date July 2020
Source Universitätsklinikum Köln
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Trained anesthesiologist- or emergency physician-divers will perform an airway management in simulated microgravity on a submerged model.


Description:

Trained anesthesiologist- or emergency physician-divers participate in the study. Simulated microgravity during spaceflight is obtained by using a submerged model. Full-torso manikins is going to be used for performing airway management. Each diver attempted airway management with each device (laryngeal mask, laryngeal tube, orotracheal intubation with video-assisted laryngoscope. The time for airway protection will be measured as well as the success rate.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Anaesthesiologist with diver licence or Emergency physician with diver license

Exclusion Criteria:

- All other

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Airway management with a submerged model
Airway management with a submerged manikin using different airway devices in randomized order

Locations

Country Name City State
Germany University Hospital of Cologne Cologne NRW

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of inserts Summarizing the number of Intubation attempts or attempts to place the supraglottic airway after 5 minutes
Primary Time to first ventilation Time from beginning with the airway manoeuvre (taking the decice) until successful airway secure and first ventilation after 5 minutes
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