Clinical trial NCT06153160: "The Effect of the Use of an Autotransfusion Device on Hemodynamic Parameters During Resuscitation".
Official title: "The Effect of the Use of an Autotransfusion HemaShock Device on Hemodynamic Parameters During Resuscitation"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Out of Hospital Cardiac Arrest
Cardiac Arrest
Keywords: Cardiac Arrest
Out of Hospital Cardiac Arrest
Resuscitation
Lead sponsor: University Medical Centre Maribor
Sponsor class: OTHER
Collaborators: name: OHK Medical Devices
First posted: 2023-12-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure
timeFrame: Immediately after arrival to the victim
measure: End tidal CO2 (Carbon dioxide) after intubation
timeFrame: Immediately after an intubation
measure: End tidal CO2 (Carbon dioxide) after application of Hemashock Socks
timeFrame: Immediately after an application of Hemashock Socks
measure: End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
timeFrame: 5 minutes after the first application of HemaShock socks
measure: End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
timeFrame: 10 minutes after the first application of HemaShock socks
measure: End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
timeFrame: 15 minutes after the first application of HemaShock socks
measure: End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
timeFrame: 20 minutes after the first application of HemaShock socks
measure: End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
timeFrame: 25 minutes after the first application of HemaShock socks
measure: End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks
timeFrame: 30 minutes after the first application of HemaShock socks
measure: End tidal CO2 (Carbon dioxide) after removal of HemaShock Socks
timeFrame: Immediately after the removal of HemaShock socks
measure: Blood pressure
timeFrame: Immediately after ROSC
Secondary outcomes:
measure: Cerebral Performance Category Scale
timeFrame: Through study completion, an average of 1 year
measure: Tissue/skin malfunction under HemaShock Socks
timeFrame: From removal of the HemaShock socks up to 15 weeks
Other outcomes:
Locations:
city: Maribor
country: Slovenia
facility: Community health center Maribor, Prehospital unit
city: Maribor
country: Slovenia
facility: Maribor University Medical Centre
Study officials:
References:
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.
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.
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.
citation: 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.
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.