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

Sponsor

University Medical Centre Maribor (Other)

Overall Status

Recruiting

CT.gov ID

NCT06153160

Collaborator

OHK Medical Devices (Other)

Enrollment

Locations

Arms

12.3

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Out of Hospital Cardiac Arrest Cardiac Arrest	Device: HemaShock device	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 22, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Blood pressure [Immediately after arrival to the victim]
Non-invasive blood pressure (both systolic and diastolic blood pressure) will be measured.
End tidal CO2 (Carbon dioxide) after intubation [Immediately after an intubation]
capnography
End tidal CO2 (Carbon dioxide) after application of Hemashock Socks [Immediately after an application of Hemashock Socks]
capnography
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks [5 minutes after the first application of HemaShock socks]
capnography
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks [10 minutes after the first application of HemaShock socks]
capnography
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks [15 minutes after the first application of HemaShock socks]
capnography
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks [20 minutes after the first application of HemaShock socks]
capnography
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks [25 minutes after the first application of HemaShock socks]
capnography
End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks [30 minutes after the first application of HemaShock socks]
capnography
End tidal CO2 (Carbon dioxide) after removal of HemaShock Socks [Immediately after the removal of HemaShock socks]
capnography
Blood pressure [Immediately after ROSC]
Noninvasive blood pressure ((both systolic and diastolic blood pressure)) after removal of HemaShock Socks

Secondary Outcome Measures

Cerebral Performance Category Scale [Through study completion, an average of 1 year]
Neurological outcome assessed with Cerebral Performance Category Scale (CPC). CPC 1-2 means good outcome, CPC 3-5 means poor outcome.
Tissue/skin malfunction under HemaShock Socks [From removal of the HemaShock socks up to 15 weeks]
Irrigation, oedema, tissue malperfusion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Community health center Maribor, Prehospital unit	Maribor		Slovenia	2000
2	Maribor University Medical Centre	Maribor		Slovenia	2000

Sponsors and Collaborators

University Medical Centre Maribor
OHK Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University Medical Centre Maribor

ClinicalTrials.gov Identifier:

NCT06153160

Other Study ID Numbers:

HemaShock socks

First Posted:

Dec 1, 2023

Last Update Posted:

Dec 1, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Medical Centre Maribor

Cardiac Arrest

Out of Hospital Cardiac Arrest

Resuscitation

Additional relevant MeSH terms:

Heart Arrest

Out-of-Hospital Cardiac Arrest

Study Results

No Results Posted as of Dec 1, 2023