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Cardiac Arrest Bundle of CARE Trial

NCT05917717 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-12-02

No results posted yet for this study

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.

Conditions

  • Cardiopulmonary Resuscitation
  • Cardiac Arrest
  • Out of Hospital Cardiac Arrest

Interventions

PROCEDURE

Neuroprotective 'bundle of care'

This includes the 3 devices: * Head up cardiopulmonary resuscitation (HUP-CPR) * Active compression decompression CPR * Impedance threshold device (ITD)

Sponsors & Collaborators

  • University of Southampton

    collaborator OTHER

  • South Central Ambulance service

    collaborator UNKNOWN

  • Hampshire and Isle of Wight air Ambulance

    collaborator UNKNOWN

  • University Hospital Southampton NHS Foundation Trust

    lead OTHER

Principal Investigators

  • James Plumb, PhD · University Hospital Southampton NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-24
Primary Completion
2025-04-30
Completion
2025-08-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05917717 on ClinicalTrials.gov