Dataset Information

Cardioplegia practice in paediatric cardiac surgery: a UK & Ireland survey.

ABSTRACT: INTRODUCTION:Many techniques are available for cardioplegic arrest in children, but there is a lack of late phase clinical trials to guide practice. We surveyed paediatric cardiac surgeons and perfusionists to establish current practice and willingness to change within a clinical trial. METHODS:An online survey was sent to all consultant paediatric cardiac surgeons and chief perfusionists in paediatric centres in the UK and Ireland. Information was sought on cardioplegia type, composition, temperature, topical cooling, dosing for induction and maintenance, interval between doses, whether practice changed with patient age or complexity and whether respondents would be willing and able to use different cardioplegia solutions within a randomised trial. RESULTS:Responses were obtained from 32 (78.0%) surgeons and 12 (100%) perfusionists. Twenty-seven (84.4%) surgeons use blood cardioplegia in infants, with St. Thomas' Harefield preparation the most popular (19, 59.4%), used routinely in eight (66.7%) centres. Twenty-two (68.8%) administer at 4-6°C, 18 (56.3%) use topical cooling, 18 (56.3%) give 30 ml/kg induction and 15 ml/kg maintenance, with 23 (71.9%) re-dosing every 20-25 minutes. Thirty (93.8%) surgeons were open to randomising patients in a trial, with del Nido (29, 90.6%) the most popular. CONCLUSIONS:This survey demonstrates heterogeneity in cardioplegia practice. Whilst most surgeons use blood cardioplegia, there is variation in type, temperature, topical cooling, dosing and intervals. Combined with a lack of evidence from late phase trials, our findings support the presence of clinical equipoise. Surgeons are willing to change practice, suggesting that a pragmatic, multi-centre, randomised, controlled trial of cardioplegia in children is feasible.

SUBMITTER: Drury NE

PROVIDER: S-EPMC6378396 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Cardioplegia practice in paediatric cardiac surgery: a UK & Ireland survey.

Drury Nigel E NE Horsburgh Angela A Bi Rehana R Willetts Robert G RG Jones Timothy J TJ

Perfusion 20180810 2

<h4>Introduction</h4>Many techniques are available for cardioplegic arrest in children, but there is a lack of late phase clinical trials to guide practice. We surveyed paediatric cardiac surgeons and perfusionists to establish current practice and willingness to change within a clinical trial.<h4>Methods</h4>An online survey was sent to all consultant paediatric cardiac surgeons and chief perfusionists in paediatric centres in the UK and Ireland. Information was sought on cardioplegia type, com ...[more]

PMID: 30095360

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Project description:There has been a drive towards increased digitalisation in healthcare. The aim was to provide a snapshot of current apps, instant messaging, and smartphone photography use in paediatric emergency care. A web-based self-report questionnaire was performed. Individual physicians working in paediatric emergency care recorded their personal practice. One hundred ninety-eight medical doctors completed the survey. Eight percent of respondents had access to institutional mobile devices to run medical apps. Eighty-six percent of respondents used medical apps on their personal mobile device, with 78% using Apple iOS devices. Forty-seven percent of respondents used formulary apps daily. Forty-nine percent of respondents had between 1-5 medical apps on their personal mobile device. Respondents who used medical apps had a total of 845 medical apps installed on their personal device, accounted for by 56 specific apps. The British National Formulary (BNF/BNFc) app was installed on the personal mobile device of 96% of respondents that use medical apps. Forty percent of respondents had patient confidentiality concerns when using medical apps. Thirty-eight percent of respondents have used consumer instant messaging services, 6% secure specialist messaging services, and 29% smartphone photography when seeking patient management advice. CONCLUSION: App use on the personal mobile devices, in the absence of access to institutional devices, was widespread, especially the use of a national formulary app. Instant messaging and smartphone photography were less common. A strategic decision has to be made to either provide staff with institutional devices or use software solutions to address data governance concerns when using personal devices. What is Known: • mHealth use by junior doctors and medical students is widespread. • Clinicians' use of instant messaging apps such as WhatsApp is the widespread in the UK and Ireland, in the absence of alternatives. What is New: • Personal mobile device use was widespread in the absence of alternatives, with the British National Formulary nearly universally downloaded to physicians' personal mobile devices. • A third of respondents used instant messaging and smartphone photography on their personal mobile device when seeking patient management advice from other teams in the absence of alternatives.

Project description:BACKGROUND:The use of cardioplegia solutions as a myocardial protection technique is essential during cardiac surgery with cardiopulmonary bypass. The del Nido cardioplegia solution (DNS) has been widely used as a myocardial preservation technique for pediatric patients undergoing cardiac surgery with cardiopulmonary bypass. Its unique pharmacological features have created growing interest for adult cardiac surgery, especially for elderly patients or those with ventricular dysfunction who are more prone to ischemia-reperfusion injury. Ever since its implementation, several retrospective studies have been published to validate the efficacy, safety, and efficiency of DNS in adult patients undergoing coronary revascularization, valve replacement, or combined procedures. Recently, a meta-analysis based on nine retrospective studies was published claiming the noninferiority of DNS compared to other conventional cardioplegia solutions. Few prospective randomized studies have been conducted whose primary outcome was the assessment of DNS clinical efficacy compared to other solutions commonly used in adult patients. OBJECTIVE:The aim of this randomized clinical trial is to assess the benefits of DNS compared to Cardi-Braun blood cardioplegia solution in clinical and biochemical terms regarding myocardial protection during adult cardiac surgery. METHODS:This is the protocol of a controlled, randomized, single-center clinical trial carried out at the Puerta de Hierro Majadahonda University Hospital in Spain. A total of 474 participants over the age of 18 years undergoing elective cardiac surgery with cardiopulmonary bypass will be assigned to groups by simple randomization to receive either DNS or Cardi-Braun blood cardioplegia solution. The primary outcome will be the differences between groups in myocardial protection in biochemical terms (ie, perioperative troponin levels) and clinical terms (ie, presence of the composite variable acute cardiovascular event). The clinical trial will be carried out under conditions of respect for the fundamental rights of the person and the ethical principles that affect biomedical research with human beings, as well as in accordance with international recommendations contained in the Declaration of Helsinki and its subsequent revisions. RESULTS:The inclusion process started in 2018. Data cleaning and analyses are expected to take place in the fall of 2020 and the results are expected in January 2021. CONCLUSIONS:This study is particularly relevant as it will be one of the first to analyze the clinical effects of del Nido cardioplegia on the basis of direct myocardial protection parameters. In light of published studies, carrying out prospective studies based on primary clinical objectives with a larger sample, high-risk patients, and longer cardiopulmonary bypass times continues to be necessary. We believe that our study addresses an important gap in the knowledge of del Nido cardioplegia in adult patient cardiac surgery and will be able to clarify the possible benefits of this method in a large population of patients undergoing these procedures. TRIAL REGISTRATION:European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) 2017-005144-14; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2017-005144-14+; ClinicalTrials.gov NCT04094168; https://clinicaltrials.gov/ct2/show/NCT04094168. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17826.

Project description:IntroductionClinical research within Paediatric Intensive Care (PICU) is necessary to reduce morbidity and mortality associated within this resource-intensive environment. With UK PICUs encouraged to be research-active there was a drive to understand how centres support research delivery.AimTo identify the research workforce available within UK/Ireland PICUs to support clinical research delivery.MethodAn electronic survey, endorsed by the Paediatric Critical Care Society (PCCS), was designed and reported in accordance with CHERRIES guidelines. The survey was distributed by email to all UK/Ireland Nurse Managers and Medical/ Nursing Research leads, aiming for one response per site during the period of April-June 2021. Only one response per site was included in analysis.Results44 responses were received, representing 24/30 UK/Ireland sites (80% response rate). Responses from n = 21/30 units are included (three excluded for insufficient data). 90% (n = 19/21) units were research active, although only 52% (n = 11) had permanent research roles funded within their staffing establishment. The majority of units (n = 18, 86%) had less than two WTE research nurses. Resources were felt to be sufficient for current research delivery by 43% of units (n = 9), but this confidence diminished to 19% (n = 4) when considering their ability to support future research. The top barriers to research conduct were insufficiently funded/unfunded studies (52%; n = 11), clinical staff too busy to support research activity (52%; n = 11) and short-term/fixed-term contracts for research staff (38%; n = 8).ConclusionDespite the perceived importance of research and 90% of responding UK/Ireland PICUs being research active, the majority have limited resources to support research delivery. This has implications for their ability to participate in future multi-centre trials and opportunities to support the development of future medical/nursing clinical academics. Further work is required to identify optimum models of clinical research delivery.

Project description:BackgroundBlood-based cardioplegia is the standard myocardial protection strategy in pediatric cardiac surgery. Custadiol (histidine-tryptophan-ketoglutarate), an alternative, may have some advantages but is potentially less effective at myocardial protection. This study aimed to test whether custadiol is not inferior to blood-based cardioplegia in pediatric cardiac surgery.MethodsThe study was designed as a randomized controlled trial with a blinded outcome assessment. All pediatric patients undergoing cardiac surgery with cardiopulmonary bypass and cardioplegia, including neonates, were eligible. Emergency surgery was excluded. The primary outcome was a composite of death within 30 days, an ICU stay longer than 5 days, or arrhythmia requiring intervention. Secondary endpoints included total hospital stay, inotropic score, cardiac troponin levels, ventricular function, and extended survival postdischarge. The sample size was determined a priori for a noninferiority design with an expected primary outcome of 40% and a clinical significance difference of 20%.ResultsBetween January 2018 and January 2021, 226 patients, divided into the Custodiol cardioplegia (CC) group (n = 107) and the blood cardioplegia (BC) group (n = 119), completed the study protocol. There was no difference in the composite endpoint between the CC and BC groups, 65 (60.75%) vs. 71 (59.66%), respectively (P = 0.87). The total length of stay in the hospital was 14 (Q2-Q3: 10-19) days in the CC group vs. 13 (10-21) days in the BC group (P = 0.85). The inotropic score was not significantly different between the CC and BC groups, 5 (2.6-7.45) vs. 5 (2.6-7.5), respectively (P = 0.82). The cardiac troponin level and ventricular function did not differ significantly between the two groups (P = 0.34 and P = 0.85, respectively). The median duration of follow-up was 32.75 (Q2-Q3: 18.73-41.53) months, and there was no difference in survival between the two groups (log-rank P = 0.55).ConclusionsCustodial cardioplegia is not inferior to blood cardioplegia for myocardial protection in pediatric patients. Trial registration The trial was registered in Clinicaltrials.gov, and the ClinicalTrials.gov Identifier number is NCT03082716 Date: 17/03/2017.

Dataset Information

Cardioplegia practice in paediatric cardiac surgery: a UK & Ireland survey.

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Cardioplegia practice in paediatric cardiac surgery: a UK & Ireland survey.

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