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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-22

Study Completion Date

2025-03-01

Brief Summary

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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.

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Detailed Description

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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.

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.

Conditions

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Out of Hospital Cardiac Arrest Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with HemaShock device

12 patients in cardiac arrest will receive HemaShock device during resuscitation.

All other interventions will be made following guidelines.

Group Type EXPERIMENTAL

HemaShock device

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes