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Clinical Trials/NCT06153160
NCT06153160
Completed
Not Applicable

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

University Medical Centre Maribor2 sites in 1 country24 target enrollmentNovember 22, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Out of Hospital Cardiac Arrest
Sponsor
University Medical Centre Maribor
Enrollment
24
Locations
2
Primary Endpoint
Blood pressure
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 22, 2023
End Date
March 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Medical Centre Maribor
Responsible Party
Sponsor

Eligibility Criteria

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
  • trauma patients

Outcomes

Primary Outcomes

Blood pressure

Time Frame: Immediately after ROSC

Noninvasive blood pressure ((both systolic and diastolic blood pressure)) after removal of HemaShock Socks

End tidal CO2 (Carbon dioxide) after intubation

Time Frame: Immediately after an intubation

capnography

End tidal CO2 (Carbon dioxide) every 5 minutes after first application of Hemashock Socks

Time Frame: 30 minutes after the first application of HemaShock socks

capnography

End tidal CO2 (Carbon dioxide) after application of Hemashock Socks

Time Frame: Immediately after an application of Hemashock Socks

capnography

End tidal CO2 (Carbon dioxide) after removal of HemaShock Socks

Time Frame: Immediately after the removal of HemaShock socks

capnography

Secondary Outcomes

  • Tissue/skin malfunction under HemaShock Socks(From removal of the HemaShock socks up to 15 weeks)
  • Cerebral Performance Category Scale(Through study completion, an average of 1 year)

Study Sites (2)

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