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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest; Out of Hospital Cardiac Arrest
• Intervention / Treatment: Device: HemaShock device

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Maribor, Slovenia, 2000
    • Recruiting
    • Community health center Maribor, Prehospital unit
    • Contact: Matej Strnad, MD, PhD; Phone Number: + 386 51 225 448; Email: strnad.matej78@gmail.com
  • Maribor, Slovenia, 2000
    • Recruiting
    • Maribor University Medical Centre
    • Contact: Maruša Esih, MD; Phone Number: +38640501631; Email: esih.marusa@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with HemaShock device; 12 patients in cardiac arrest will receive HemaShock device during resuscitation. All other interventions will be made following guidelines.	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.
No Intervention: Patients with-out HemaShock device; 12 patients in cardiac arrest will not receive HemaShock device during resuscitation. All other interventions will be made following guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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	Irrigation, oedema, tissue malperfusion	From removal of the HemaShock socks up to 15 weeks

Collaborators and Investigators

• Sponsor: University Medical Centre Maribor
• Collaborators: OHK Medical Devices

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Cardiac Arrest; Resuscitation; Out of Hospital Cardiac Arrest
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: HemaShock socks

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No