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

Primary Purpose

Airway Management, Emergency Medicine

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Airway management with a submerged model

About this trial

This is an interventional other trial for Airway Management

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Anaesthesiologist with diver licence or Emergency physician with diver license

Exclusion Criteria:

All other

Sites / Locations

University Hospital of Cologne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Airway device placement

Arm Description

airway device is placed during the dive

Outcomes

Primary Outcome Measures

Number of inserts

Summarizing the number of Intubation attempts or attempts to place the supraglottic airway

Time to first ventilation

Time from beginning with the airway manoeuvre (taking the decice) until successful airway secure and first ventilation

Secondary Outcome Measures

Full Information

NCT ID

NCT03848559

First Posted

February 14, 2019

Last Updated

July 23, 2020

Sponsor

Universitätsklinikum Köln

1. Study Identification

Unique Protocol Identification Number

NCT03848559

Brief Title

Airway Management With Simulated Microgravity Using a Submerged Model

Acronym

AirMicroMod

Official Title

Airway Management With Simulated Microgravity Using a Submerged Model

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

April 30, 2020 (Actual)

Study Completion Date

May 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitätsklinikum Köln

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Airway Management, Emergency Medicine

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Airway device placement

Arm Type

Experimental

Arm Description

airway device is placed during the dive

Intervention Type

Device

Intervention Name(s)

Airway management with a submerged model

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of inserts

Description

Summarizing the number of Intubation attempts or attempts to place the supraglottic airway

Time Frame

after 5 minutes

Title

Time to first ventilation

Description

Time from beginning with the airway manoeuvre (taking the decice) until successful airway secure and first ventilation

Time Frame

after 5 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Anaesthesiologist with diver licence or Emergency physician with diver license Exclusion Criteria: All other

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jochen Hinkelbein, MD, PhD

Organizational Affiliation

UK Köln

Official's Role

Study Chair

Facility Information:

Facility Name

University Hospital of Cologne

City

Cologne

State/Province

NRW

ZIP/Postal Code

50937

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Airway Management With Simulated Microgravity Using a Submerged Model

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