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

Study Overview
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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.

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.

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

Conditions
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Out of Hospital Cardiac Arrest, Cardiac Arrest

Intervention / Treatment
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* Device: HemaShock device


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with HemaShock device<br>12 patients in cardiac arrest will receive HemaShock device during resuscitation. All other interventions will be made following guidelines. | Device: HemaShock device<br>* 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.<br>|
| No Intervention: Patients with-out HemaShock device<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Arrest, Out of Hospital Cardiac Arrest, Resuscitation