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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04354883
Recruitment Status : Completed
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Köln

Tracking Information
First Submitted Date  ICMJE April 2, 2020
First Posted Date  ICMJE April 21, 2020
Last Update Posted Date April 21, 2020
Actual Study Start Date  ICMJE January 2, 2020
Actual Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
  • total number of chest compressions [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    defined as >2 cm of compression depth
  • number of correct chest compressions [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    defined as 50-60 mm of depth
  • compression rate [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    defined as any compression of the thorax
  • correct compression rate [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    defined as 100-120 compressions min-1
  • depth rate [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    defined as 50-60 mm of depth
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
  • no-flow-time [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    time without effective compression after the onset of chest compressions
  • thorax release [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    correct thorax release after compression
  • Self-Satisfaction-Score [ Time Frame: 60 Seconds, Questionnaire filled out by participants after dive ]
    Depth Frequency Feasibility Exhaustion All in All Quality
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Schmitz-Hinkelbein Method. A New Technique for CPR in Space.
Official Title  ICMJE The Schmitz-Hinkelbein Method. A New Method for the Performance of External Chest Compressions During Microgravity.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Arrest
Intervention  ICMJE Procedure: External Chest Compressions on Manikin in Underwater Setting
Two different methods of CPR in an analogue model of mircogravity
Study Arms  ICMJE
  • Active Comparator: Schmitz-Hinkelbein-Method
    Intervention: Procedure: External Chest Compressions on Manikin in Underwater Setting
  • Active Comparator: Hinkelbein-Schmitz-Method
    Intervention: Procedure: External Chest Compressions on Manikin in Underwater Setting
Publications * Schmitz J, Ahlbäck A, DuCanto J, Kerkhoff S, Komorowski M, Löw 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). pii: 646. doi: 10.3390/jcm11030646.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2020)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 1, 2020
Actual Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04354883
Other Study ID Numbers  ICMJE 19-1069_1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Universitätsklinikum Köln
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Universitätsklinikum Köln
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universitätsklinikum Köln
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP