Clinical Trials Directory

Trials / Completed

CompletedNCT06153160

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
University Medical Centre Maribor · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEHemaShock deviceThe 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.

Timeline

Start date
2023-11-22
Primary completion
2024-12-30
Completion
2025-03-01
First posted
2023-12-01
Last updated
2025-03-30

Locations

2 sites across 1 country: Slovenia

Source: ClinicalTrials.gov record NCT06153160. Inclusion in this directory is not an endorsement.