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

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

Study Overview

• Status: Completed
• Conditions: Emergency Medicine; Airway Management
• Intervention / Treatment: Device: Airway management with a submerged model

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Cologne, NRW, Germany, 50937
      • University Hospital of Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Anaesthesiologist with diver licence or Emergency physician with diver license

Exclusion Criteria:

• All other

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitätsklinikum Köln
• Investigators: Study Chair: Jochen Hinkelbein, MD, PhD, UK Köln

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 20, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: AirMicroMod

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No