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The Schmitz-Hinkelbein Method. A New Technique for CPR in Space.

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
External Chest Compressions on Manikin in Underwater Setting
Sponsored by
Universitätsklinikum Köln
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiopulmonary resuscitation, CPR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • University Hospital of Cologne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Schmitz-Hinkelbein-Method

Hinkelbein-Schmitz-Method

Arm Description

Outcomes

Primary Outcome Measures

total number of chest compressions
defined as >2 cm of compression depth
number of correct chest compressions
defined as 50-60 mm of depth
compression rate
defined as any compression of the thorax
correct compression rate
defined as 100-120 compressions min-1
depth rate
defined as 50-60 mm of depth

Secondary Outcome Measures

no-flow-time
time without effective compression after the onset of chest compressions
thorax release
correct thorax release after compression
Self-Satisfaction-Score
Depth Frequency Feasibility Exhaustion All in All Quality

Full Information

First Posted
April 2, 2020
Last Updated
April 20, 2020
Sponsor
Universitätsklinikum Köln
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1. Study Identification

Unique Protocol Identification Number
NCT04354883
Brief Title
The Schmitz-Hinkelbein Method. A New Technique for CPR in Space.
Official Title
The Schmitz-Hinkelbein Method. A New Method for the Performance of External Chest Compressions During Microgravity.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
April 1, 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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. The investigators conducted a randomized controlled manikin trial and asked 15 participants with valid diving-license to resuscitate a manikin in two different techniques of CPR in a free-floating position underwater. The first technique, (Schmitz-Hinkelbein-Method) is similar to conventional CPR, with the patient in a supine position on the performer's knees for stabilization. The second technique (Hinkelbein-Schmitz-Method) is similar to the first, but chest compressions are conducted with the elbow.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiopulmonary resuscitation, CPR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Schmitz-Hinkelbein-Method
Arm Type
Active Comparator
Arm Title
Hinkelbein-Schmitz-Method
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
External Chest Compressions on Manikin in Underwater Setting
Intervention Description
Two different methods of CPR in an analogue model of mircogravity
Primary Outcome Measure Information:
Title
total number of chest compressions
Description
defined as >2 cm of compression depth
Time Frame
60 seconds video clip with afterwards evaluation
Title
number of correct chest compressions
Description
defined as 50-60 mm of depth
Time Frame
60 seconds video clip with afterwards evaluation
Title
compression rate
Description
defined as any compression of the thorax
Time Frame
60 seconds video clip with afterwards evaluation
Title
correct compression rate
Description
defined as 100-120 compressions min-1
Time Frame
60 seconds video clip with afterwards evaluation
Title
depth rate
Description
defined as 50-60 mm of depth
Time Frame
60 seconds video clip with afterwards evaluation
Secondary Outcome Measure Information:
Title
no-flow-time
Description
time without effective compression after the onset of chest compressions
Time Frame
60 seconds video clip with afterwards evaluation
Title
thorax release
Description
correct thorax release after compression
Time Frame
60 seconds video clip with afterwards evaluation
Title
Self-Satisfaction-Score
Description
Depth Frequency Feasibility Exhaustion All in All Quality
Time Frame
60 Seconds, Questionnaire filled out by participants after dive

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: any acute or chronic ENT illness/injury no valid diving/EMT license
Facility Information:
Facility Name
University Hospital of Cologne
City
Cologne
State/Province
Northrhine-Westphalia
ZIP/Postal Code
50937
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35160097
Citation
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.
Results Reference
derived

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The Schmitz-Hinkelbein Method. A New Technique for CPR in Space.

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