NCT04354883

Brief Summary

The risk of a severe medical event during long-duration spaceflight is significant and can endanger both the whole mission and crew. There is a certain risk for a cardiac arrest in space requiring cardiopulmonary resuscitation (CPR). So far, 5 known techniques to perform CPR in microgravity have been reported. The aim of the present study was to describe and gather data for two new CPR techniques useful in microgravity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

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

Study Start

First participant enrolled

January 2, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 2, 2020

Last Update Submit

April 20, 2020

Conditions

Keywords

cardiopulmonary resuscitationCPR

Outcome Measures

Primary Outcomes (5)

  • total number of chest compressions

    defined as \>2 cm of compression depth

    60 seconds video clip with afterwards evaluation

  • number of correct chest compressions

    defined as 50-60 mm of depth

    60 seconds video clip with afterwards evaluation

  • compression rate

    defined as any compression of the thorax

    60 seconds video clip with afterwards evaluation

  • correct compression rate

    defined as 100-120 compressions min-1

    60 seconds video clip with afterwards evaluation

  • depth rate

    defined as 50-60 mm of depth

    60 seconds video clip with afterwards evaluation

Secondary Outcomes (3)

  • no-flow-time

    60 seconds video clip with afterwards evaluation

  • thorax release

    60 seconds video clip with afterwards evaluation

  • Self-Satisfaction-Score

    60 Seconds, Questionnaire filled out by participants after dive

Study Arms (2)

Schmitz-Hinkelbein-Method

ACTIVE COMPARATOR
Procedure: External Chest Compressions on Manikin in Underwater Setting

Hinkelbein-Schmitz-Method

ACTIVE COMPARATOR
Procedure: External Chest Compressions on Manikin in Underwater Setting

Interventions

Two different methods of CPR in an analogue model of mircogravity

Hinkelbein-Schmitz-MethodSchmitz-Hinkelbein-Method

Eligibility Criteria

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

You may qualify if:

  • Valid diving-license(SSI - Open Water Diver (OWD), CMAS \*, PADI Open Water Diver, ISO 24801-2 (Autonomous Diver), NAUI Scuba Diver or equal license
  • German EMT-qualification

You may not qualify if:

  • any acute or chronic ENT illness/injury
  • no valid diving/EMT license

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Related Publications (1)

  • Schmitz J, Ahlback A, DuCanto J, Kerkhoff S, Komorowski M, Low V, Russomano T, Starck C, Thierry S, Warnecke T, Hinkelbein J. Randomized Comparison of Two New Methods for Chest Compressions during CPR in Microgravity-A Manikin Study. J Clin Med. 2022 Jan 27;11(3):646. doi: 10.3390/jcm11030646.

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2020

First Posted

April 21, 2020

Study Start

January 2, 2020

Primary Completion

March 30, 2020

Study Completion

April 1, 2020

Last Updated

April 21, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations