"The Effect of the Use of an Autotransfusion Device on Hemodynamic Parameters During Resuscitation".
- Conditions
- Out of Hospital Cardiac ArrestCardiac Arrest
- Interventions
- Device: HemaShock device
- Registration Number
- NCT06153160
- Lead Sponsor
- University Medical Centre Maribor
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- OHCA (Out of Hospital Cardiac Arrest)
- age > 18 years
- intubated
- meets criteria for resuscitation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients with HemaShock device HemaShock device 12 patients in cardiac arrest will receive HemaShock device during resuscitation. All other interventions will be made following guidelines.
- Primary Outcome Measures
Name Time Method Blood pressure Immediately after ROSC Noninvasive blood pressure ((both systolic and diastolic blood pressure)) after removal of HemaShock Socks
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 30 minutes after the first application of HemaShock socks capnography
End tidal CO2 (Carbon dioxide) after application of Hemashock Socks Immediately after an application of Hemashock Socks capnography
End tidal CO2 (Carbon dioxide) after removal of HemaShock Socks Immediately after the removal of HemaShock socks capnography
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (2)
Community health center Maribor, Prehospital unit
đŸ‡¸đŸ‡®Maribor, Slovenia
Maribor University Medical Centre
đŸ‡¸đŸ‡®Maribor, Slovenia