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Trials ; 19(1): 55, 2018 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-29357947


BACKGROUND: In addition to pain, sickle cell anaemia (HbSS) complications include neurocognitive difficulties in attention and processing speed associated with low daytime and night-time oxygen saturation compounded by obstructive sleep apnoea (OSA). In the general population OSA is treated with continuous positive airways pressure (CPAP). The aim of this single-blind, randomised, controlled phase II trial is to compare auto-adjusting CPAP (APAP) with standard care to standard care alone in individuals with HbSS to determine whether the intervention improves attention and processing speed, brain structure, pain and quality of life. METHODS/DESIGN: Eligibility criteria include: ability to provide informed consent; age > 8 years; diagnosis of HbSS; and mean overnight saturation of < 90% for < 30% of the night (i.e. not meeting current criteria for overnight oxygen therapy). Key exclusion criteria are: overnight respiratory support; respiratory or decompensated cardiac failure; chronic transfusion; or contraindications to APAP therapy or magnetic resonance imaging (MRI). Sixty individuals with HbSS (30 children and 30 adults) will be randomised to standard care + APAP or standard care alone for six months. Minimisation factors are: age group (8-11, 12-15, 16-22 and > 23 years); silent infarction on MRI; minimum overnight oxygen saturation > 90% or < 90%; and hydroxyurea use. For APAP individuals, the intervention is administered at home. Adherence and effectiveness are recorded using software documenting hours of use each night and overnight oximetry. Participant support in terms of appropriate facemask and facilitating adherence are provided by an unblinded sleep physiologist. The primary outcome is change in the cancellation subtest from the Wechsler scales. Secondary outcomes include general cognitive functioning, quantitative brain MRI, blood and urine chemistry, quality of life and daily pain via a smartphone App (GoMedSolutions, Inc) and, where possible MRI heart, echocardiography, and 6-min walk. These outcomes will be assessed at baseline and after six months of treatment by assessors blind to treatment assignment. DISCUSSION: Altering oxygen saturation in HbSS may lead to bone marrow suppression. This risk will be reduced by monitoring full blood counts at baseline, two weeks, three months and six months, providing treatment as appropriate and reporting as safety events. TRIAL REGISTRATION: ISRCTN46012373 . Registered on 10 July 2015. Protocol Version: 6.0 Date: 24th December 2015 Sponsor: University Hospital Southampton. Sponsor's protocol code: RHMCHIOT53.

Adv Simul (Lond) ; 2: 16, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29450017


Aims and background: Distributed Simulation is the concept of portable, high-fidelity immersive simulation. Here, it is used for the development of a simulation-based training programme for cardiovascular specialities. We present an evidence base for how accessible, portable and self-contained simulated environments can be effectively utilised for the modelling, development and testing of a complex training framework and assessment methodology. Iterative user feedback through mixed-methods evaluation techniques resulted in the implementation of the training programme. Approach: Four phases were involved in the development of our immersive simulation-based training programme: (1) initial conceptual stage for mapping structural criteria and parameters of the simulation training framework and scenario development (n = 16), (2) training facility design using Distributed Simulation, (3) test cases with clinicians (n = 8) and collaborative design, where evaluation and user feedback involved a mixed-methods approach featuring (a) quantitative surveys to evaluate the realism and perceived educational relevance of the simulation format and framework for training and (b) qualitative semi-structured interviews to capture detailed feedback including changes and scope for development. Refinements were made iteratively to the simulation framework based on user feedback, resulting in (4) transition towards implementation of the simulation training framework, involving consistent quantitative evaluation techniques for clinicians (n = 62). For comparative purposes, clinicians' initial quantitative mean evaluation scores for realism of the simulation training framework, realism of the training facility and relevance for training (n = 8) are presented longitudinally, alongside feedback throughout the development stages from concept to delivery, including the implementation stage (n = 62). Findings: Initially, mean evaluation scores fluctuated from low to average, rising incrementally. This corresponded with the qualitative component, which augmented the quantitative findings; trainees' user feedback was used to perform iterative refinements to the simulation design and components (collaborative design), resulting in higher mean evaluation scores leading up to the implementation phase. Conclusions: Through application of innovative Distributed Simulation techniques, collaborative design, and consistent evaluation techniques from conceptual, development, and implementation stages, fully immersive simulation techniques for cardiovascular specialities are achievable and have the potential to be implemented more broadly.

Circ Cardiovasc Imaging ; 9(12)2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-27940957


BACKGROUND: Conventional cardiopulmonary exercise testing can objectively measure exercise intolerance but cannot provide comprehensive evaluation of physiology. This requires additional assessment of cardiac output and arteriovenous oxygen content difference. We developed magnetic resonance (MR)-augmented cardiopulmonary exercise testing to achieve this goal and assessed children with right heart disease. METHODS AND RESULTS: Healthy controls (n=10) and children with pulmonary arterial hypertension (PAH; n=10) and repaired tetralogy of Fallot (n=10) underwent MR-augmented cardiopulmonary exercise testing. All exercises were performed on an MR-compatible ergometer, and oxygen uptake was continuously acquired using a modified metabolic cart. Simultaneous cardiac output was measured using a real-time MR flow sequence and combined with oxygen uptake to calculate arteriovenous oxygen content difference. Peak oxygen uptake was significantly lower in the PAH group (12.6±1.31 mL/kg per minute; P=0.01) and trended toward lower in the tetralogy of Fallot group (13.5±1.29 mL/kg per minute; P=0.06) compared with controls (16.7±1.37 mL/kg per minute). Although tetralogy of Fallot patients had the largest increase in cardiac output, they had lower resting (3±1.2 L/min per m2) and peak (5.3±1.2 L/min per m2) values compared with controls (resting 4.3±1.2 L/min per m2 and peak 6.6±1.2 L/min per m2) and PAH patients (resting 4.5±1.1 L/min per m2 and peak 5.9±1.1 L/min per m2). Both the PAH and tetralogy of Fallot patients had blunted exercise-induced increases in arteriovenous oxygen content difference. However, only the PAH patients had significantly reduced peak values (6.9±1.3 mlO2/100 mL) compared with controls (8.4±1.4 mlO2/100 mL; P=0.005). CONCLUSIONS: MR-augmented cardiopulmonary exercise testing is feasible in both healthy children and children with cardiac disease. Using this novel technique, we have demonstrated abnormal exercise patterns in oxygen uptake, cardiac output, and arteriovenous oxygen content difference.

Aptidão Cardiorrespiratória , Teste de Esforço/métodos , Tolerância ao Exercício , Hipertensão Pulmonar/diagnóstico por imagem , Imagem por Ressonância Magnética , Insuficiência da Valva Pulmonar/diagnóstico por imagem , Tetralogia de Fallot/cirurgia , Adolescente , Fatores Etários , Débito Cardíaco , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Estudos de Casos e Controles , Criança , Estudos de Viabilidade , Feminino , Nível de Saúde , Humanos , Hipertensão Pulmonar/fisiopatologia , Masculino , Variações Dependentes do Observador , Consumo de Oxigênio , Valor Preditivo dos Testes , Insuficiência da Valva Pulmonar/etiologia , Insuficiência da Valva Pulmonar/fisiopatologia , Reprodutibilidade dos Testes , Volume Sistólico , Função Ventricular Esquerda , Função Ventricular Direita
Physiol Meas ; 36(5): N85-94, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25903482


The purposes of this study were: (1) to evaluate feasibility and acceptability of MRI augmented cardiopulmonary exercise testing (MR-CPET) in healthy adults and (2) to test whether peak values obtained at conventional and MR-CPET correlate and to demonstrate variation in peak oxygen consumption (VO2) relates to both peak cardiac output (CO) and peak oxygen extraction (ΔcO2). Seventeen healthy adults underwent CPET and MR-CPET using an MR compatible ergometer and CPET system customised for MR use. Continuous aortic flow measurement used a validated UNFOLD-SENSE spiral phase contrast magnetic resonance (PCMR) sequence.Fifteen of 17 volunteers completed exercise; exclusions were due to claustrophobia and inability to effectively master exercise technique. Measures of acceptability were lower but still satisfactory for MR-CPET.There were strong correlations between conventional and MR-CPET for peak VO2 (r = 0.94, p < 0.001); VCO2 (r = 0.87, p < 0.001) and VE (r = 0.88, p < 0.001).Multiple linear regression analysis demonstrated peak CO and ΔcO2 were independent predictors of peak VO2 measured during MR-CPET (ß = 0.73 and 0.38 p < 0.0001) and conventional CPET (ß = 0.78, 0.28 p < 0.0001).MR-CPET is feasible, acceptable and demonstrates physiology not apparent with conventional CPET. MR-CPET allows differentiation of the contributions of CO and ΔcO2 to variation in peak VO2. We believe that this will be useful in understanding the origin of reduced exercise capacity in cardiac disease.

Teste de Esforço/métodos , Imagem por Ressonância Magnética , Adulto , Débito Cardíaco , Estudos de Viabilidade , Feminino , Voluntários Saudáveis , Humanos , Masculino , Consumo de Oxigênio
Regen Med ; 9(3): 269-78, 2014 May.
Artigo em Inglês | MEDLINE | ID: mdl-24935040


AIM: This study presents an interim safety and feasibility analysis of the REGENERATE-IHD randomized controlled trial, which is examining the safety and efficacy of three different delivery routes of bone marrow-derived stem cells (BMSCs) in patients with ischemic heart failure. METHODS & RESULTS: The first 58 patients recruited to the REGENERATE-IHD study are included in this interim analysis (pilot). Symptomatic patients with ischemic heart failure were randomized to receive subcutaneous granulocyte colony-stimulating factor or saline injections only; or subcutaneous granulocyte colony-stimulating factor injections followed by intracoronary or intramyocardial injections of BMSCs or serum (control). No significant differences were found in terms of safety and feasibility between the different delivery routes, with no significant difference in procedural complications or major adverse cardiac events. There was a signal towards improved heart failure symptoms in the patients treated with intramyocardial injection of mobilized BMSCs. CONCLUSION: Peripheral mobilization of BMSCs with or without subsequent direct myocardial delivery appears safe and feasible in patients with chronic ischemic heart failure.

Transplante de Medula Óssea/métodos , Vias de Administração de Medicamentos , Insuficiência Cardíaca/terapia , Coração , Miocárdio , Fator Estimulador de Colônias de Granulócitos/administração & dosagem , Fator Estimulador de Colônias de Granulócitos/farmacologia , Humanos , Peptídeo Natriurético Encefálico/administração & dosagem , Peptídeo Natriurético Encefálico/farmacologia , Fragmentos de Peptídeos/administração & dosagem , Fragmentos de Peptídeos/farmacologia , Projetos Piloto , Transplante Autólogo