Title: Improving Outcomes from Out of Hospital Cardiac Arrest: The Cardiac Arrest Individual Registry and Outcomes (CAIRO) Programme
Funder: Department of Health (England)

Abstract: PROGRAMME DEVELOPMENT SUMMARY This 18 month schedule of development will address the challenges identified under each WP of the proposed programme grant. It draws upon the same multidisciplinary team, CTEU and network of national and international experts, and further develops and consolidates this collaboration. The development grant is divided into four work packages (A-D) that mirror the four work packages of the proposed programme grant (1-4). See also the accompanying Gantt chart. WORK PACKAGE A Summary Demonstrate the feasibility of the CAIRO database. Objectives Demonstrate that the CAIRO database, and the required data linkages, can be successfully established. Obtain the necessary ethical, research and governance approvals. Identify the most appropriate outcome measures following OHCA. Demonstrate that the CAIRO database is likely to prove cost effective. Methodology A Bristol CTEU database manager will work with a research paramedic (covering pre-hospital data collection) and a research nurse (covering in-hospital data collection) to develop a pilot of the CAIRO database under the supervision of the applicant team. Ethical, regulatory and governance hurdles will be identified and overcome, and the database will be evaluated against pre-defined measures of data completeness and accuracy. It is essential to include the most relevant outcome measures from clinical, patient and health economic perspectives. Members of the research team will attend the forthcoming revision of the Utstein template, which forms the core dataset for OHCA research. In addition, we are working with Prof. Gavin Perkins at Warwick University to ensure that the CAIRO database is compatible with the forthcoming national OHCA registry, and additional work to define a core outcome dataset using Core Outcome Measures in Effectiveness Trials (COMET) methodology (http://www.comet-initiative.org/). Thus CAIRO will be fully integrated with the latest international developments in OHCA outcome measures. We will also estimate the costs associated with setting up, implementing and updating the CAIRO database to determine whether it is likely to represent good value for money for the NHS. Success Criteria The creation of a clinically effective and cost effective pilot database, incorporating established and emerging outcome measures and with the necessary approvals for use. WORK PACKAGE B Summary Demonstrate the value of undertaking a thorough exploration of the ways in which OHCA outcomes may be influenced by ambulance systems and ambulance clinicians. Objectives Establish detailed pre-hospital data collection within the CAIRO database. Undertake a preliminary analysis of CAIRO data to confirm the existence of variability in resuscitation decision-making. Methodology The research paramedic will build on existing high-quality data collection within the regional ambulance service to ensure completion of the necessary data fields. The CTEU will then undertake a preliminary data analysis to scope variability and possible associations. Success Criteria Confirmation of suspected variation, with potential for further detailed analysis. WORK PACKAGE C Summary Demonstrate the feasibility of our proposed randomised trial of controlled versus 100% oxygen following ROSC, and estimate the required sample size. Objectives Demonstrate that the proposed study design is feasible. Identify the most appropriate primary outcome measure. Finalise the study sample size and demonstrate that this is achievable. Gain the necessary ethics, MHRA and research governance approvals. Identify the main cost drivers for the trial interventions and most appropriate methods to collect economic data. Methodology Small feasibility study. The project’s research paramedic will work with the study team to establish whether: A. Paramedics can titrate the inspired oxygen concentration following OHCA to achieve a target oxygen saturation. B. A reliable reading of oxygen saturation can be obtained immediately after ROSC. C. The allocated treatment strategy can be continued for one hour following ROSC (often requires continuation into the receiving emergency department). We will: Identify which ventilators are available within the regional ambulance service and the facilities that they have for adjusting the inspired oxygen concentration. Train a cohort of 40 paramedics, targeting those most likely to attend OHCA. Develop a package to train the participating paramedics to confirm a reliable reading of SpO2 from the pulse oximeter once ROSC has been achieved and then to reduce the flow of oxygen until the patient’s oxygen saturation is in the range 94 – 98%. Document the first arterial blood gas values obtained after arrival at the emergency department. Obtain the necessary NHS ethics, MHRA and research governance approvals. We will also identify the best study outcome measure. Because only patients who achieve ROSC following OHCA are eligible, the sample size required to show a small difference in mortality would be prohibitively large. Crude mortality is also problematic because it does not take account of the quality of life achieved by survivors. We have drawn up a short list-of potential outcome measures (incorporating quality of life and neurological function), and will explore these further to decide upon an optimal approach. This will permit the calculation of a sample size for the main study. Success Criteria Necessary approvals granted. Evidence that paramedics can titrate the inspired oxygen concentration and obtain a reliable reading of oxygen saturation immediately after ROSC (i.e. that the intervention can be initiated). Evidence that the patient’s assigned oxygen therapy can be continued for 60 min after ROSC (i.e. that the intervention can be continued). Agreement on a primary outcome measure, calculation of a realistic sample size and sufficient ambulance service engagement to achieve this. WORK PACKAGE D Summary Preparation for the implementation study that will follow, finalising the care bundle and ensuring that effective collaboration can be achieved. Objectives Identify current use of post OHCA care bundles in UK ICUs Access existing ICU networks to create a collaborative group willing to implement a post OHCA bundle. Complete a gap analysis at participating ICUs. Develop and finalise the care bundle at the lead centre, and scope implementation tools. Methodology We will complete an Intensive Care Society-sponsored UK telephone survey of senior nurses/duty consultant on the intensive care unit, following a previously established methodology (Binks, 2010). There are 30 hospitals admitting OHCA patients in the South West and West Midlands. These ICUs are members of two critical care networks, and have collaborated successfully on research projects and quality improvement initiatives. Units will be invited to participate as part of their critical care networks, supported by printed materials, personal contacts and a project website. ICUs willing to participate will be visited by the project research nurse to provide further information and complete a one-day gap analysis to identify areas where the recommended guidance is not currently being implemented. Most of the required care bundle is already in place at the lead centre (UHBristol), but further steps will be taken to ensure complete adherence. This will be followed by a scoping exercise to identify and quantify the tools that will be required for successful implementation. The optimal method of data collection and feedback from the collaborating centres will be identified. Success Criteria At least 75% response to survey. At least 30 ICUs agreed to join the OHCA collaborative and stepped wedge initiative. Gap analysis completed in at least 20 ICUs. Care bundle fully implemented at the lead centre; implementation tools identified. PROJECT MANAGEMENT The Chief Investigator will oversee the four work packages and coordinate the activity of the employed research staff to ensure successful delivery. Each work package will be led by a named co-applicant. Progress will be reviewed and plans for the subsequent programme grant refined at four half-day collaboration meetings. We have already held four such meetings to date. An overall project advisory group, drawn from national and international experts in OHCA, is being formed and will receive regular reports, providing feedback and guidance. Many of these individuals have already been identified and agreed to collaborate. Early dissemination activity will occur towards the end of the programme development stage as appropriate.


Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: CARDIOVASCULAR