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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04354883
Other study ID # 19-1069_1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2020
Est. completion date April 1, 2020

Study information

Verified date April 2020
Source Universitätsklinikum Köln
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date April 1, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
External Chest Compressions on Manikin in Underwater Setting
Two different methods of CPR in an analogue model of mircogravity

Locations

Country Name City State
Germany University Hospital of Cologne Cologne Northrhine-Westphalia

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Köln

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary total number of chest compressions defined as >2 cm of compression depth 60 seconds video clip with afterwards evaluation
Primary number of correct chest compressions defined as 50-60 mm of depth 60 seconds video clip with afterwards evaluation
Primary compression rate defined as any compression of the thorax 60 seconds video clip with afterwards evaluation
Primary correct compression rate defined as 100-120 compressions min-1 60 seconds video clip with afterwards evaluation
Primary depth rate defined as 50-60 mm of depth 60 seconds video clip with afterwards evaluation
Secondary no-flow-time time without effective compression after the onset of chest compressions 60 seconds video clip with afterwards evaluation
Secondary thorax release correct thorax release after compression 60 seconds video clip with afterwards evaluation
Secondary Self-Satisfaction-Score Depth Frequency Feasibility Exhaustion All in All Quality 60 Seconds, Questionnaire filled out by participants after dive
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