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| Name | Class |
|---|---|
| OHK Medical Devices | UNKNOWN |
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The purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation.
24 people will be included in the pilot study (12 people will be included in the intervention group - with the usage of "autotransfusion socks" during resuscitation and 12 people in the control group - without "autotransfusion socks"). Investigators will compare the hemodynamic parameters and also neurological outcome between both groups.
The purpose of the research (pilot study) is to determine the impact of the use of the autotransfusion device on hemodynamic parameters during resuscitation.
Out-of-hospital cardiac arrest (OHCA) is one of the leading causes of death in Europe.
In order to improve the hemodynamic parameters during resuscitation, device for autotransfusion was developed. Devices are basically a very strong elastic stockings that also block arterial circulation. While "putting on" stockings, blood is being squeezed from the lower extremities (approximately 500 ml of blood for each lower limb). With blood being squeezed from the lower limb into the central circulation the filling of the heart is being improved; thus the device will improve the preload and also cardiac output.
A study done on an animal model showed that during resuscitation using "autotransfusion socks" increases both systolic and diastolic blood pressure during resuscitation, the perfusion of the coronary arteries improves and also the values of the partial pressure of carbon dioxide increases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with HemaShock device | Experimental | 12 patients in cardiac arrest will receive HemaShock device during resuscitation. All other interventions will be made following guidelines. |
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| Patients with-out HemaShock device | No Intervention | 12 patients in cardiac arrest will not receive HemaShock device during resuscitation. All other interventions will be made following guidelines. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HemaShock device | Device | The HemaShock is a tight silicone ring attached to a pressure stocking. It comes wrapped into a doughnut and has a set of handles. The operator simply puts the doughnut over the foot or hand, and pulls on the handles to unravel the HemaShock while applying pressure throughout the appendage. The device displace blood from limbs to central blood system, thus improving preload and cardiac output. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Non-invasive blood pressure (both systolic and diastolic blood pressure) will be measured. | Immediately after arrival to the victim |
| End tidal CO2 (Carbon dioxide) after intubation | capnography | Immediately after an intubation |
| End tidal CO2 (Carbon dioxide) after application of Hemashock Socks | capnography | Immediately after an application of Hemashock Socks |
| End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks | capnography | 5 minutes after the first application of HemaShock socks |
| End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks | capnography | 10 minutes after the first application of HemaShock socks |
| End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks | capnography | 15 minutes after the first application of HemaShock socks |
| End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks | capnography | 20 minutes after the first application of HemaShock socks |
| End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Performance Category Scale | Neurological outcome assessed with Cerebral Performance Category Scale (CPC). CPC 1-2 means good outcome, CPC 3-5 means poor outcome. | Through study completion, an average of 1 year |
| Tissue/skin malfunction under HemaShock Socks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maribor University Medical Centre | Maribor | Urban Municipality of Maribor | 2000 | Slovenia | ||
| Community health center Maribor, Prehospital unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25326102 | Background | Boyce LW, Vliet Vlieland TP, Bosch J, Wolterbeek R, Volker G, van Exel HJ, Heringhaus C, Schalij MJ, Goossens PH. High survival rate of 43% in out-of-hospital cardiac arrest patients in an optimised chain of survival. Neth Heart J. 2015 Jan;23(1):20-5. doi: 10.1007/s12471-014-0617-x. | |
| 33773835 | Background |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
capnography |
| 25 minutes after the first application of HemaShock socks |
| End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks | capnography | 30 minutes after the first application of HemaShock socks |
| End tidal CO2 (Carbon dioxide) after removal of HemaShock Socks | capnography | Immediately after the removal of HemaShock socks |
| Blood pressure | Noninvasive blood pressure ((both systolic and diastolic blood pressure)) after removal of HemaShock Socks | Immediately after ROSC |
Irrigation, oedema, tissue malperfusion |
| From removal of the HemaShock socks up to 15 weeks |
| Maribor |
| 2000 |
| Slovenia |
| Olasveengen TM, Semeraro F, Ristagno G, Castren M, Handley A, Kuzovlev A, Monsieurs KG, Raffay V, Smyth M, Soar J, Svavarsdottir H, Perkins GD. European Resuscitation Council Guidelines 2021: Basic Life Support. Resuscitation. 2021 Apr;161:98-114. doi: 10.1016/j.resuscitation.2021.02.009. Epub 2021 Mar 24. |
| 33773825 | Background | Soar J, Bottiger BW, Carli P, Couper K, Deakin CD, Djarv T, Lott C, Olasveengen T, Paal P, Pellis T, Perkins GD, Sandroni C, Nolan JP. European Resuscitation Council Guidelines 2021: Adult advanced life support. Resuscitation. 2021 Apr;161:115-151. doi: 10.1016/j.resuscitation.2021.02.010. Epub 2021 Mar 24. |
| 29503830 | Background | Aminiahidashti H, Shafiee S, Zamani Kiasari A, Sazgar M. Applications of End-Tidal Carbon Dioxide (ETCO2) Monitoring in Emergency Department; a Narrative Review. Emerg (Tehran). 2018;6(1):e5. Epub 2018 Jan 15. |
| 25447436 | Background | Yang Z, Tang D, Wu X, Hu X, Xu J, Qian J, Yang M, Tang W. A tourniquet assisted cardiopulmonary resuscitation augments myocardial perfusion in a porcine model of cardiac arrest. Resuscitation. 2015 Jan;86:49-53. doi: 10.1016/j.resuscitation.2014.10.009. Epub 2014 Oct 23. |