Dataset Information

Feasibility of data linkage in the PARAMEDIC trial: a cluster randomised trial of mechanical chest compression in out-of-hospital cardiac arrest.

ABSTRACT:

Objectives

There is considerable interest in reducing the cost of clinical trials. Linkage of trial data to administrative datasets and disease-specific registries may improve trial efficiency, but it has not been reported in resuscitation trials conducted in the UK. To assess the feasibility of using national administrative and clinical datasets to follow up patients transported to hospital following attempted resuscitation in a cluster randomised trial of a mechanical chest compression device in out-of-hospital cardiac arrest.

Methods

Hospital data on trial participants were requested from Hospital Episode Statistics (HES), the Intensive Care National Audit and Research Centre, and Myocardial Ischaemia National Audit Project and National Audit of Percutaneous Coronary Interventions, using unique patient identifiers. Linked data were received between June 2014 and June 2015.

Results

Of 4471 patients randomised in the pre-hospital randomised assessment of a mechanical compression device in cardiac arrest (PARAMEDIC) trial, 2398 (53.6%) were not known to be deceased at emergency department arrival and were eligible for linkage. We achieved an overall match rate of 86.7% in the combined HES accident and emergency, inpatient and critical care dataset, with variable match rates (4.2%-80.4%) in individual datasets. Patient demographics, cardiac arrest-related characteristics and major outcomes were predominantly similar between HES matched and unmatched groups, in the linkage apart from location, response time and return of spontaneous circulation (ROSC) at handover.

Conclusions

This study shows that it is feasible to track patients from the prehospital setting through to hospital admission using routinely available administrative datasets with a moderate to high degree of success. This approach has the potential to complement the trial data with the demographic and clinical management information about the studied cohort, as well as to improve the efficiency and reduce the costs of follow-up in cardiac arrest trials.

Clinical trial registration

ISRCTN08233942; Post-results.

SUBMITTER: Ji C

PROVIDER: S-EPMC6067361 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Project description:BackgroundCardiac arrest (CA) is a serious threat to human health. Cardiopulmonary resuscitation (CPR) is an effective treatment for CA. Early and high-quality CPR is closely related to the survival rate of patients with CA. But manual chest compression has a lot of defects. To solve the defects and improve the quality of CPR, mechanical CPR device was invented. However, it has still controversy whether manual chest compression or mechanical chest compression is better. This systematic review was aimed to investigate the difference in clinical outcomes between manual chest compression and Lund University Cardiac Assist System (LUCAS) assisted CPR in patients with out-hospital CA.MethodsOriginal research studies, conducted on adult out-of-hospital CA, were included. PubMed/Medline, EMBASE, Scopus, Cochrane Library, CNKI, and Wanfang database were searched from the setting to February 21, 2019. Odds ratio (OR) with 95% confidence interval (CI) was selected as effect scale index for evaluation of the difference in return of spontaneous circulation (ROSC), survival to hospital admission, survival to hospital discharge, and survival to 30 days. Random effects model was used in this study to estimate overall mean effects.ResultsA total of 6 articles, including 4 randomized controlled trials and 2 nonrandomized controlled trials, were selected. And 8501 subjects were involved to analyze the clinical outcomes of LUCAS and manual chest compression for patients with out-hospital CA. Comparisons of ROSC (33.3% vs 33.0%, P?=?.98; OR?=?1; 95% CI: [0.89,1.13]), survival to hospital admission (22.7% vs 24.3%, P?=?.32; OR?=?0.86; 95% CI: [0.65,1.15]), survival to hospital discharge (8.6% vs 10.7%, P?=?.50; OR?=?0.92; 95% CI: [0.73,1.17]), and survival to 30 days (7.5% vs 8.5%, P?=?.50; OR?=?0.92; 95% CI: [0.73,1.17]) were made. No significant difference was found.ConclusionThe synthesis of available evidence does not support that mechanical chest compression with LUCAS device improves clinical outcome in out-of-hospital CA patients compared with manual chest compression. Large scale studies with improved designs are still needed in the future.

Project description:BACKGROUND:Current guidelines underline the importance of high-quality chest compression during cardiopulmonary resuscitation (CPR), to improve outcomes. Contrary to this many studies show that chest compression is often carried out poorly in clinical practice, and long interruptions in compression are observed. This prospective cohort study aimed to analyse whether chest compression quality changes when a real-time feedback system is used to provide simultaneous audiovisual feedback on chest compression quality. For this purpose, pauses in compression, compression frequency and compression depth were compared. METHODS:The study included 292 out-of-hospital cardiac arrests in three consecutive study groups: first group, conventional resuscitation (no-sensor CPR); second group, using a feedback sensor to collect compression depth data without real-time feedback (sensor-only CPR); and third group, with real-time feedback on compression quality (sensor-feedback CPR). Pauses and frequency were analysed using compression artefacts on electrocardiography, and compression depth was measured using the feedback sensor. With this data, various parameters were determined in order to be able to compare the chest compression quality between the three consecutive groups. RESULTS:The compression fraction increased with sensor-only CPR (group 2) in comparison with no-sensor CPR (group 1) (80.1% vs. 87.49%; P < 0.001), but there were no further differences belonging compression fraction after activation of sensor-feedback CPR (group 3) (P = 1.00). Compression frequency declined over the three study groups, reaching the guideline recommendations (127.81 comp/min vs. 122.96 comp/min, P = 0.02 vs. 119.15 comp/min, P = 0.008) after activation of sensor-feedback CPR (group 3). Mean compression depth only changed minimally with sensor-feedback (52.49 mm vs. 54.66 mm; P = 0.16), but the fraction of compressions with sufficient depth (at least 5 cm) and compressions within the recommended 5-6 cm increased significantly with sensor-feedback CPR (56.90% vs. 71.03%; P = 0.003 and 28.74% vs. 43.97%; P < 0.001). CONCLUSIONS:The real-time feedback system improved chest compression quality regarding pauses in compression and compression frequency and facilitated compliance with the guideline recommendations. Compression depth did not change significantly after activation of the real-time feedback. Even the sole use of a CPR-feedback-sensor ("sensor-only CPR") improved performance regarding pauses in compression and compression frequency, a phenomenon known as the 'Hawthorne effect'. Based on this data real-time feedback systems can be expected to raise the quality level in some parts of chest compression quality. TRIAL REGISTRATION:International Clinical Trials Registry Platform of the World Health Organisation and German Register of Clinical Trials (DRKS00009903), Registered 09 February 2016 (retrospectively registered).

Project description:IntroductionWhether ultrasonography (US) contributes to delays in chest compressions and hence a negative impact on survival is uncertain. In this study we aimed to investigate the impact of US on chest compression fraction (CCF) and patient survival.MethodsWe retrospectively analyzed video recordings of the resuscitation process in a convenience sample of adult patients with non-traumatic, out-of-hospital cardiac arrest. Patients receiving US once or more during resuscitation were categorized as the US group, while the patients who did not receive US were categorized as the non-US group. The primary outcome was CCF, and the secondary outcomes were the rates of return of spontaneous circulation (ROSC), survival to admission and discharge, and survival to discharge with a favorable neurological outcome between the two groups. We also evaluated the individual pause duration and the percentage of prolonged pauses associated with US.ResultsA total of 236 patients with 3,386 pauses were included. Of these patients, 190 received US and 284 pauses were related to US. Longer resuscitation duration was observed in the US group (median, 30.3 vs 9.7 minutes, P<.001). The US group had comparable CCF (93.0% vs 94.3%, P=0.29) with the non-US group. Although the non-US group had a better rate of ROSC (36% vs 52%, P=0.04), the rates of survival to admission (36% vs 48%, P=0.13), survival to discharge (11% vs 15%, P=0.37), and survival with favorable neurological outcome (5% vs 9%, P=0.23) did not differ between the two groups. The pause duration of pulse checks with US was longer than pulse checks alone (median, 8 vs 6 seconds, P=0.02). The percentage of prolonged pauses was similar between the two groups (16% vs 14%, P=0.49).ConclusionWhen compared to the non-ultrasound group, patients receiving US had comparable chest compression fractions and rates of survival to admission and discharge, and survival to discharge with a favorable neurological outcome. The individual pause was lengthened related to US. However, patients without US had a shorter resuscitation duration and a better rate of ROSC. The trend toward poorer results in the US group was possibly due to confounding variables and nonprobability sampling. It should be better investigated in further randomized studies.

Project description:BACKGROUND:With a survival rate of 6 to 11%, out-of-hospital cardiac arrest (OHCA) remains a healthcare challenge with room for improvement in morbidity and mortality. The guidelines emphasize the highest possible quality of cardiopulmonary resuscitation (CPR) and chest compressions (CC). It is essential to minimize CC interruptions, and therefore increase the chest compression fraction (CCF), as this is an independent factor for survival. Survival is significantly and positively correlated with the suitability of CCF targets, CC frequency, CC depth, and brief predefibrillation pause. CC guidance improves adherence to recommendations and allows closer alignment with the CC objectives. The possibility of improving CCF by lengthening the time between two CC relays and the effect of real-time feedback on the quality of the CC must be investigated. METHODS:Using a 2?×?2 factorial design in a multicenter randomized trial, two hypotheses will be tested simultaneously: (i) a 4-min relay rhythm improves the CCF (reducing the no-flow time) compared to the currently recommended 2-min relay rate, and (ii) a guiding tool improves the quality of CC. Primary outcomes (i) CCF and (ii) correct compression score will be recorded by a real-time feedback device. Five hundred adult nontraumatic OHCAs will be included over 2?years. Patients will be randomized in a 1:1:1:1 distribution receiving advanced CPR as follows: 2-min blind, 2?min with guidance, 4-min blind, or 4?min with guidance. Secondary outcomes are the depth, frequency, and release of CC; length (care, no-flow, and low-flow); rate of return of spontaneous circulation; characteristics of advanced CPR; survival at hospital admission; survival and neurological state on days 1 and 30 (or intensive care discharge); and dosage of neuron-specific enolase on days 1 and 3. DISCUSSION:This study will contribute to assessing the impact of real-time feedback on CC quality in practical conditions of OHCA resuscitation. It will also provide insight into the feasibility of extending the relay rhythm between two rescuers from the currently recommended 2 to 4?min. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03817892 . Registered on 28 January 2019.