CABARET

  • Research type

    Research Study

  • Full title

    Cardiac Arrest Bundle of cARE Trial (Short title: CABARET)

  • IRAS ID

    329970

  • Contact name

    Charles Deakin

  • Contact email

    charles.deakin@nhs.net

  • Sponsor organisation

    University Hospital Southampton NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT05917717

  • Duration of Study in the UK

    1 years, 0 months, 13 days

  • Research summary

    Out-of-hospital cardiac arrest (OOHCA) is a common and critical event in the UK, with approximately 60,000 cases per year. Survival rates for OOHCA remain poor, ranging from 2-12% in the UK, while exemplar global systems like Seattle and Norway achieve higher survival rates of 21% and 25% respectively. Several factors contribute to the variability in outcomes, including the availability of defibrillators, bystander CPR proficiency, emergency response times, training of personnel, access to interventions like percutaneous coronary intervention, and extracorporeal resuscitation.

    Promising data from animal and cadaver studies suggest that new technological devices could enhance blood flow during cardiopulmonary resuscitation (CPR), particularly cerebral blood flow. The combination of three devices offers a potential solution to improve organ perfusion during CPR and subsequently enhance survival rates. These devices include: a) head-up position (HUP-CPR) that elevates the head to improve cerebral blood flow; b) active compression/decompression CPR, which generates negative intrathoracic pressure, enhancing venous return to the heart; and c) an impedance threshold device (ITD) that limits air entry during chest recoil, further enhancing intrathoracic pressure reduction.

    While retrospective data showed improved outcomes with the use of active compression/decompression CPR, ITD, and HUP-CPR, a prospective human study is currently underway in France. These devices are already approved for use, eliminating the need for additional regulatory approvals.

    To address the persistently low survival rates and the potential benefits indicated by previous studies, a pilot randomized cluster cross over trial is proposed. This trial aims to assess the feasibility and effectiveness of a "bundle of care" approach incorporating the three devices mentioned above. By comparing usual care with this comprehensive approach, which synergistically improves cerebral and coronary blood flow, the study seeks to validate the possible benefits observed in animal studies and retrospective data.

    The research objective is to determine the impact of the "bundle of care" approach on patient outcomes after OOHCA. By evaluating the combination of head-up CPR, active compression/decompression CPR, and ITD in a randomized trial, the study aims to improve survival rates and neurological outcomes. This research is crucial to confirm the potential benefits of these devices and bridge the gap in survival rates between different healthcare systems.

  • REC name

    South Central - Oxford C Research Ethics Committee

  • REC reference

    23/SC/0304

  • Date of REC Opinion

    4 Oct 2023

  • REC opinion

    Favourable Opinion