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NCT06153160 Clinical Trial

"The Effect of the Use of an Autotransfusion Device on Hemodynamic Parameters During Resuscitation".

Cardiac Arrest Clinical Trial

Official title:
"The Effect of the Use of an Autotransfusion HemaShock Device on Hemodynamic Parameters During Resuscitation"

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06153160
Other study ID # HemaShock socks
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 22, 2023
Est. completion date December 1, 2024

Study information
Verified date March 2023
Source University Medical Centre Maribor
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 24
Est. completion date December 1, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - OHCA (Out of Hospital Cardiac Arrest) - age > 18 years - intubated - meets criteria for resuscitation Exclusion Criteria: - age < 18 years - not intubated - clinical signs for DVT (deep vein thrombosis), PE (pulmonary embolism) - clinical signs of acute inflammation of limbs, broken limbs etc. - known oncological patient - asphyxia - trauma patients

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• HemaShock 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.

Locations
Country Name City State
Slovenia Community health center Maribor, Prehospital unit Maribor
Slovenia Maribor University Medical Centre Maribor

Sponsors (2)
Lead Sponsor Collaborator
University Medical Centre Maribor OHK Medical Devices

Country where clinical trial is conducted

Slovenia, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Resuscitation. 2021 Oct;167:105-106. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Blood pressure Non-invasive blood pressure (both systolic and diastolic blood pressure) will be measured. Immediately after arrival to the victim
Primary End tidal CO2 (Carbon dioxide) after intubation capnography Immediately after an intubation
Primary End tidal CO2 (Carbon dioxide) after application of Hemashock Socks capnography Immediately after an application of Hemashock Socks
Primary End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks capnography 5 minutes after the first application of HemaShock socks
Primary End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks capnography 10 minutes after the first application of HemaShock socks
Primary End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks capnography 15 minutes after the first application of HemaShock socks
Primary End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks capnography 20 minutes after the first application of HemaShock socks
Primary End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks capnography 25 minutes after the first application of HemaShock socks
Primary End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks capnography 30 minutes after the first application of HemaShock socks
Primary End tidal CO2 (Carbon dioxide) after removal of HemaShock Socks capnography Immediately after the removal of HemaShock socks
Primary Blood pressure Noninvasive blood pressure ((both systolic and diastolic blood pressure)) after removal of HemaShock Socks Immediately after ROSC
Secondary 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
Secondary Tissue/skin malfunction under HemaShock Socks Irrigation, oedema, tissue malperfusion From removal of the HemaShock socks up to 15 weeks
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