Actively Recruiting

Phase Not Applicable
Age: 18Years - 120Years
All Genders
ID05917717

Cardiac Arrest Bundle of Care Trial Using Head-Up CPR, Active Compression-Decompression CPR, and Impedance Threshold Device

Led by University Hospital Southampton NHS Foundation Trust · Updated on 2024-12-02

32

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

U

University Hospital Southampton NHS Foundation Trust

Lead Sponsor

U

University of Southampton

Collaborating Sponsor

AI-Summary

What this Trial Is About

Out-of-hospital cardiac arrest (OOHCA) is a sudden event where the heart stops beating, causing vital organs to lose blood flow and shut down. In the UK, about 60,000 people experience OOHCA annually, with survival rates remaining low despite emergency services. Researchers are studying whether a combination of three devices can improve blood flow during resuscitation and increase survival rates with good brain function after cardiac arrest. The study compares usual care with a "bundle of care" approach that uses three devices together: head-up position CPR (Elegard), active compression-decompression mechanical CPR (Lucas-3), and an impedance threshold device (Resqpod-16). In the intervention group, emergency teams will apply these devices along with standard CPR, including placing the impedance threshold device on the airway, activating the head elevation device after 2 minutes of CPR, and possibly intubating if needed. Resuscitation continues for at least 30 minutes or until the heart restarts. The control group receives standard CPR without these devices. Participants will be monitored throughout resuscitation, with assessments including cardiac rhythms, signs of life during CPR, carbon dioxide levels, return of spontaneous circulation, survival to hospital handover, and neurological outcomes at 30 days using the modified Rankin Scale. The study will also evaluate the feasibility of using the device bundle and training emergency staff. Participation lasts through the emergency event and includes follow-up up to 30 days for survival and neurological status.

CONDITIONS

Brief Title

Cardiac Arrest Bundle of cARE Trial

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients over 18 years of age who have suffered a cardiac arrest
  • Body size compatible with the bundle devices
  • Cardiac arrest was witnessed
  • Time of collapse known to be within 20 minutes
Not Eligible

You will not qualify if you...

  • Visibly pregnant women
  • Prisoners
  • Cardiac arrest caused by trauma
  • Cardiac arrest caused by drowning
  • Cardiac arrest caused by hanging
  • Do Not Attempt Cardiopulmonary Resuscitation (DNACPR) orders
  • Cardiac arrest duration estimated at 21 minutes or more

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Treatment

Duration - At least 30 minutes or until return of spontaneous circulation (ROSC) is achieved

Participants receive emergency care for out-of-hospital cardiac arrest using either usual care or a bundle of care approach that includes head-up CPR, active compression-decompression CPR, and an impedance threshold device during resuscitation.

Emergency treatment period with continuous monitoring

Follow-up

Duration - Up to 30 days after treatment

Participants are monitored after resuscitation for survival, neurological outcomes, and other clinical assessments up to 30 days.

Hospital visits and assessments during hospitalization and up to 30 days

Trial Site Locations

Total: 1 location

1

University Hospital Southampton NHS Foundation trust

Southampton, England, United Kingdom, SO16 6YD

Actively Recruiting

Loading map...

Research Team

J

James OM Plumb, PhD

M

Martina Brown

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Evaluation of Electrocardiographic Data From High-risk Cardi...

Cardiomyopathies

Actively Recruiting

14 locations

Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE ...

Cardiac Arrest

Actively Recruiting

4 locations

Brain Heart InterActioNs in Cardiac Arrest Ancillary Study o...

Cardiac Arrest

Actively Recruiting

5 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Global incidences of out-of-hospital cardiac arrest and survival rates: Systematic review of 67 prospective studies.

Jocelyn Berdowski, Robert A Berg, Jan G P Tijssen...

https://pubmed.ncbi.nlm.nih.gov/20828914

Good outcome in every fourth resuscitation attempt is achievable--an Utstein template report from the Stavanger region.

Thomas Werner Lindner, Eldar Søreide, Odd Bjarte Nilsen...

https://pubmed.ncbi.nlm.nih.gov/21752524

Controlled sequential elevation of the head and thorax combined with active compression decompression cardiopulmonary resuscitation and an impedance threshold device improves neurological survival in a porcine model of cardiac arrest.

Johanna C Moore, Bayert Salverda, Carolina Rojas-Salvador...

https://pubmed.ncbi.nlm.nih.gov/33027619

Head and thorax elevation during active compression decompression cardiopulmonary resuscitation with an impedance threshold device improves cerebral perfusion in a swine model of prolonged cardiac arrest.

Johanna C Moore, Nicolas Segal, Michael C Lick...

https://pubmed.ncbi.nlm.nih.gov/28827197

A new variant position of head-up CPR may be associated with improvement in the measurements of cranial near-infrared spectroscopy suggestive of an increase in cerebral blood flow in non-traumatic out-of-hospital cardiac arrest patients: A prospective interventional pilot study.

Dong Won Kim, Jong Kwan Choi, Seung Hyun Won...

https://pubmed.ncbi.nlm.nih.gov/35395338

Head and thorax elevation during cardiopulmonary resuscitation using circulatory adjuncts is associated with improved survival.

Johanna C Moore, Paul E Pepe, Kenneth A Scheppke...

https://pubmed.ncbi.nlm.nih.gov/35933057

European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation.

Gavin D Perkins, Anthony J Handley, Rudolph W Koster...

https://pubmed.ncbi.nlm.nih.gov/26477420