Cardiac Arrest Bundle of Care Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

An out-of-hospital cardiac arrest is a sudden event where the heart stops beating and a person becomes unresponsive. During this event, vital organs in the body receive no blood flow, causing them to shut down. Without intervention to restart the heart, a person effectively dies. In the UK, around 60,000 people experience cardiac arrests each year, with most occurring at home. Despite prompt emergency service response, survival rates are typically low. There is technology available that has the potential to improve survival rates for out-of-hospital cardiac arrests. The intervention involves three devices used together: head-up position CPR (Elegard), active compression-decompression mechanical CPR (Lucas-3), and the Impedance Threshold device (Resqpod-16). When combined, these devices can enhance blood flow during resuscitation, potentially leading to improved initial resuscitation rates and higher rates of survival with normal brain function after a cardiac arrest. A pilot study is planned to test the feasibility of using these devices. The results will inform the design of a larger study to determine if this technology can indeed improve survival rates in out-of-hospital cardiac arrests.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• Adult patients (\>18 year of age) who have suffered a cardiac arrest

• Body habitus is compatible with the bundle devices.

• Witnessed event

• Time of collapse was known with reasonable certainty to have been to be within 20 minutes.

Locations
Other Locations
United Kingdom
University Hospital Southampton NHS Foundation trust
RECRUITING
Southampton
Contact Information
Primary
James OM Plumb, PhD
j.plumb@soton.ac.uk
07967319438
Backup
Martina Brown
martina.brown@scas.nhs.uk
Time Frame
Start Date: 2024-05-24
Estimated Completion Date: 2025-08-30
Participants
Target number of participants: 32
Treatments
No_intervention: Control (usual care)
Usual care for a cardiac arrest patient with no deviation.
Experimental: Intervention 'bundle of care'
The clinical team will follow a specific sequence of actions using three devices (Elegard, Lucas-3, and ITD-16), in addition to standard CPR. Firstly, they will place the ITD onto the i-gel) or ETT, followed by the Elegard device and the LUCAS-3. The team will also place a cerebral saturation monitor on (Near-Infrared Spectroscopy (NIRS)) (if they have access to one). After 2 minutes of CPR via the LUCAS-3 with the ResQPOD-16 (ITD), the Elegard device will be turned on and activated to gradually elevate the head approximately 22cm from the ground to the back of the occiput. If necessary, the clinical team may choose to intubate the trachea at this point. Resuscitation will continue for at least 30 minutes or until ROSC is achieved. If ROSC is achieved, standard post ROSC guidelines will be followed.
Related Therapeutic Areas
Sponsors
Collaborators: Hampshire and Isle of Wight air Ambulance, South Central Ambulance service, University of Southampton
Leads: University Hospital Southampton NHS Foundation Trust

This content was sourced from clinicaltrials.gov