Cardiac ArrestNCT04354883
The Schmitz-Hinkelbein Method. A New Technique for CPR in Space.
A study testing External Chest Compressions on Manikin in Underwater Setting in people with Cardiac Arrest, run by Universitätsklinikum Köln at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- External Chest Compressions on Manikin in Underwater Setting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jan 2020to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any acute or chronic ENT illness/injury
- no valid diving/EMT license
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Arrest
- Being tested
- External Chest Compressions on Manikin in Underwater Setting
- Keywords
- cardiopulmonary resuscitation, CPR
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Chest Compressions on Manikin in Underwater SettingProcedure or surgery
Two different methods of CPR in an analogue model of mircogravity
| Study group | Role | What they receive |
|---|---|---|
| Schmitz-Hinkelbein-Method | Active comparator | Not described Receives: Procedure: External Chest Compressions on Manikin in Underwater Setting |
| Hinkelbein-Schmitz-Method | Active comparator | Not described Receives: Procedure: External Chest Compressions on Manikin in Underwater Setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
total number of chest compressions
defined as >2 cm of compression depth
Measured: 60 seconds video clip with afterwards evaluation
number of correct chest compressions
defined as 50-60 mm of depth
Measured: 60 seconds video clip with afterwards evaluation
compression rate
defined as any compression of the thorax
Measured: 60 seconds video clip with afterwards evaluation
correct compression rate
defined as 100-120 compressions min-1
Measured: 60 seconds video clip with afterwards evaluation
depth rate
defined as 50-60 mm of depth
Measured: 60 seconds video clip with afterwards evaluation
Secondary outcomes (3)
no-flow-time
time without effective compression after the onset of chest compressions
Measured: 60 seconds video clip with afterwards evaluation
thorax release
correct thorax release after compression
Measured: 60 seconds video clip with afterwards evaluation
Self-Satisfaction-Score
Depth Frequency Feasibility Exhaustion All in All Quality
Measured: 60 Seconds, Questionnaire filled out by participants after dive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start2 Jan 2020
- Primary completion30 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Köln
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354883
- Sponsor's protocol ID
- 19-1069_1
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35160097
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Schmitz-Hinkelbein Method. A New Method for the Performance of External Chest Compressions During Microgravity.
- ClinicalTrials.gov ID
- NCT04354883
- Acronym / sponsor ID
- 19-1069_1
- Conditions
- Cardiac Arrest
- Keywords
- cardiopulmonary resuscitation, CPR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Universitätsklinikum KölnUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schmitz-Hinkelbein-Method | Active comparator | Procedure: External Chest Compressions on Manikin in Underwater Setting |
| Hinkelbein-Schmitz-Method | Active comparator | Procedure: External Chest Compressions on Manikin in Underwater Setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- any acute or chronic ENT illness/injury
- no valid diving/EMT license
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Chest Compressions on Manikin in Underwater SettingTwo different methods of CPR in an analogue model of mircogravity | Procedure or surgery | Hinkelbein-Schmitz-Method, Schmitz-Hinkelbein-Method |
Primary outcome
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
3 secondary outcomes
no-flow-time
Time frame: 60 seconds video clip with afterwards evaluation
thorax release
Time frame: 60 seconds video clip with afterwards evaluation
Self-Satisfaction-Score
Time frame: 60 Seconds, Questionnaire filled out by participants after dive
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Derived from this study: PubMed 35160097Schmitz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Chest Compressions on Manikin in Underwater Setting in people with Cardiac Arrest, run by Universitätsklinikum Köln at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total number of chest compressions (time frame: 60 seconds video clip with afterwards evaluation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04354883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.