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Airway Management With Simulated Microgravity Using a Submerged Model (AirMicroMod)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03848559
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Köln

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

Condition or disease Intervention/treatment Phase
Airway Management Emergency Medicine Device: Airway management with a submerged model Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Airway Management With Simulated Microgravity Using a Submerged Model
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : May 30, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Airway device placement
airway device is placed during the dive
 Device: Airway management with a submerged model
Airway management with a submerged manikin using different airway devices in randomized order


Outcome Measures
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Primary Outcome Measures :
  1. Number of inserts [ Time Frame: after 5 minutes ]
    Summarizing the number of Intubation attempts or attempts to place the supraglottic airway

  2. Time to first ventilation [ Time Frame: after 5 minutes ]
    Time from beginning with the airway manoeuvre (taking the decice) until successful airway secure and first ventilation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anaesthesiologist with diver licence or Emergency physician with diver license

Exclusion Criteria:

  • All other
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848559


Locations
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Germany
University Hospital of Cologne
Cologne, NRW, Germany, 50937
Sponsors and Collaborators
Universitätsklinikum Köln
Investigators
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Study Chair: Jochen Hinkelbein, MD, PhD UK Köln
More Information
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Responsible Party: Universitätsklinikum Köln
ClinicalTrials.gov Identifier: NCT03848559    
Other Study ID Numbers: AirMicroMod
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes