Epidemiology and outcomes from out-of-hospital cardiac arrests in England.
Claire Hawkes, Scott Booth, Chen Ji...
https://pubmed.ncbi.nlm.nih.gov/27865775Actively Recruiting
Led by University Hospital Southampton NHS Foundation Trust · Updated on 2024-12-02
32
Participants Needed
1
Research Sites
17 weeks
Total Duration
U
University Hospital Southampton NHS Foundation Trust
Lead Sponsor
U
University of Southampton
Collaborating Sponsor
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
Cardiac Arrest Bundle of cARE Trial
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
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
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
Total: 1 location
1
University Hospital Southampton NHS Foundation trust
Southampton, England, United Kingdom, SO16 6YD
Actively Recruiting
J
James OM Plumb, PhD
M
Martina Brown
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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