- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04354883
The Schmitz-Hinkelbein Method. A New Technique for CPR in Space.
The Schmitz-Hinkelbein Method. A New Method for the Performance of External Chest Compressions During Microgravity.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Northrhine-Westphalia
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Cologne, Northrhine-Westphalia, Germany, 50937
- University Hospital of Cologne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Schmitz-Hinkelbein-Method
|
Two different methods of CPR in an analogue model of mircogravity
|
ACTIVE_COMPARATOR: Hinkelbein-Schmitz-Method
|
Two different methods of CPR in an analogue model of mircogravity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total number of chest compressions
Time Frame: 60 seconds video clip with afterwards evaluation
|
defined as >2 cm of compression depth
|
60 seconds video clip with afterwards evaluation
|
number of correct chest compressions
Time Frame: 60 seconds video clip with afterwards evaluation
|
defined as 50-60 mm of depth
|
60 seconds video clip with afterwards evaluation
|
compression rate
Time Frame: 60 seconds video clip with afterwards evaluation
|
defined as any compression of the thorax
|
60 seconds video clip with afterwards evaluation
|
correct compression rate
Time Frame: 60 seconds video clip with afterwards evaluation
|
defined as 100-120 compressions min-1
|
60 seconds video clip with afterwards evaluation
|
depth rate
Time Frame: 60 seconds video clip with afterwards evaluation
|
defined as 50-60 mm of depth
|
60 seconds video clip with afterwards evaluation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
no-flow-time
Time Frame: 60 seconds video clip with afterwards evaluation
|
time without effective compression after the onset of chest compressions
|
60 seconds video clip with afterwards evaluation
|
thorax release
Time Frame: 60 seconds video clip with afterwards evaluation
|
correct thorax release after compression
|
60 seconds video clip with afterwards evaluation
|
Self-Satisfaction-Score
Time Frame: 60 Seconds, Questionnaire filled out by participants after dive
|
Depth Frequency Feasibility Exhaustion All in All Quality
|
60 Seconds, Questionnaire filled out by participants after dive
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-1069_1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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