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

University Medical Centre Maribor

Status: Completed

Conditions: Out of Hospital Cardiac Arrest; Cardiac Arrest

Treatments: Device: HemaShock device

Study type: Interventional

Funder types: Other

Identifiers

NCT06153160

HemaShock socks

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Patients with HemaShock device

Experimental group

Description:

12 patients in cardiac arrest will receive HemaShock device during resuscitation. All other interventions will be made following guidelines.

Treatment:

Device: HemaShock device

Patients with-out HemaShock device

No Intervention group

Description:

12 patients in cardiac arrest will not receive HemaShock device during resuscitation. All other interventions will be made following guidelines.