Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Procedure: External Chest Compressions on Manikin in Underwater Setting Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Schmitz-Hinkelbein Method. A New Method for the Performance of External Chest Compressions During Microgravity.
Actual Study Start Date : January 2, 2020
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : April 1, 2020

Arm Intervention/treatment
Active Comparator: Schmitz-Hinkelbein-Method Procedure: External Chest Compressions on Manikin in Underwater Setting
Two different methods of CPR in an analogue model of mircogravity

Active Comparator: Hinkelbein-Schmitz-Method Procedure: External Chest Compressions on Manikin in Underwater Setting
Two different methods of CPR in an analogue model of mircogravity




Primary Outcome Measures :
  1. total number of chest compressions [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    defined as >2 cm of compression depth

  2. number of correct chest compressions [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    defined as 50-60 mm of depth

  3. compression rate [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    defined as any compression of the thorax

  4. correct compression rate [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    defined as 100-120 compressions min-1

  5. depth rate [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    defined as 50-60 mm of depth


Secondary Outcome Measures :
  1. no-flow-time [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    time without effective compression after the onset of chest compressions

  2. thorax release [ Time Frame: 60 seconds video clip with afterwards evaluation ]
    correct thorax release after compression

  3. Self-Satisfaction-Score [ Time Frame: 60 Seconds, Questionnaire filled out by participants after dive ]
    Depth Frequency Feasibility Exhaustion All in All Quality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354883


Locations
Layout table for location information
Germany
University Hospital of Cologne
Cologne, Northrhine-Westphalia, Germany, 50937
Sponsors and Collaborators
Universitätsklinikum Köln
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Universitätsklinikum Köln
ClinicalTrials.gov Identifier: NCT04354883    
Other Study ID Numbers: 19-1069_1
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Köln:
cardiopulmonary resuscitation
CPR
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Arrest
Heart Diseases
Cardiovascular Diseases