Cardiac Arrest, Out of Hospital Cardiac Arrest
Conditions
Keywords
Cardiac Arrest, Out of Hospital Cardiac Arrest, Resuscitation
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.
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.
Interventions
DEVICEHemaShock 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.
Sponsors
OHK Medical Devices
University Medical Centre Maribor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End tidal CO2 (Carbon dioxide) after intubation | Immediately after an intubation | 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) after removal of HemaShock Socks | Immediately after the removal of HemaShock socks | capnography |
| 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 application of Hemashock Socks | Immediately after an application of Hemashock Socks | capnography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tissue/skin malfunction under HemaShock Socks | From removal of the HemaShock socks up to 15 weeks | Irrigation, oedema, tissue malperfusion |
| 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. |
Countries
Slovenia
Outcome results
None listed