NCT03848559

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
Last Updated

July 27, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

February 14, 2019

Last Update Submit

July 23, 2020

Conditions

Airway ManagementEmergency Medicine

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Airway device placement

EXPERIMENTAL

airway device is placed during the dive

Device: Airway management with a submerged model

Interventions

Airway management with a submerged modelDEVICE

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

Airway device placement

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Anaesthesiologist with diver licence or Emergency physician with diver license

You may not qualify if:

  • All other

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

MeSH Terms

Interventions

Airway Management

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jochen Hinkelbein, MD, PhD

    UK Köln

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 20, 2019

Study Start

October 1, 2019

Primary Completion

April 30, 2020

Study Completion

May 30, 2020

Last Updated

July 27, 2020

Record last verified: 2020-07

Locations

DE(1)