Abstract：
OBJECTIVE: To determine whether it was feasible, safe and acceptable for ambulance clinicians to use capillary blood ketone meters for \'high-risk\' diabetic ketoacidosis (DKA) recognition and fluid initiation, to inform the need for a full-powered, multi-centre trial.
METHODS: Adopting a stepped-wedge controlled design, participants with hyperglycaemia (capillary blood glucose >11.0 mmol/L) or diabetes and unwell were recruited. \'High-risk\' DKA intervention participants (capillary blood ketones ≥3.0 mmol/L) received paramedic-led fluid therapy. Participant demographic and clinical data were collated from ambulance and hospital care records. Twenty ambulance and Emergency Department clinicians were interviewed to understand their hyperglycaemia and DKA care experiences.
RESULTS: In this study, 388 participants were recruited (Control: n = 203; Intervention: n = 185). Most presented with hyperglycaemia, and incidence of type 1 and type 2 diabetes was 18.5% and 74.3%, respectively. Ketone meter use facilitated \'high-risk\' DKA identification (control: 2.5%, n = 5; intervention: 6.5%, n = 12) and was associated with improved hospital pre-alerting. Ambulance clinicians appeared to have a high index of suspicion for hospital-diagnosed DKA participants. One third (33.3%; n = 3) of Control and almost half (45.5%; n = 5) of Intervention DKA participants received pre-hospital fluid therapy. Key interview themes included clinical assessment, ambulance DKA fluid therapy, clinical handovers; decision support tool; hospital DKA management; barriers to hospital DKA care.
CONCLUSIONS: Ambulance capillary blood ketone meter use was deemed feasible, safe and acceptable. Opportunities for improved clinical decision making, support and safety-netting, as well as in-hospital DKA care, were recognised. As participant recruitment was below progression threshold, it is recommended that future-related research considers alternative trial designs.
RESULTS: gov: NCT04940897.
METHODS: Adopting a stepped-wedge controlled design, participants with hyperglycaemia (capillary blood glucose >11.0 mmol/L) or diabetes and unwell were recruited. \'High-risk\' DKA intervention participants (capillary blood ketones ≥3.0 mmol/L) received paramedic-led fluid therapy. Participant demographic and clinical data were collated from ambulance and hospital care records. Twenty ambulance and Emergency Department clinicians were interviewed to understand their hyperglycaemia and DKA care experiences.
RESULTS: In this study, 388 participants were recruited (Control: n = 203; Intervention: n = 185). Most presented with hyperglycaemia, and incidence of type 1 and type 2 diabetes was 18.5% and 74.3%, respectively. Ketone meter use facilitated \'high-risk\' DKA identification (control: 2.5%, n = 5; intervention: 6.5%, n = 12) and was associated with improved hospital pre-alerting. Ambulance clinicians appeared to have a high index of suspicion for hospital-diagnosed DKA participants. One third (33.3%; n = 3) of Control and almost half (45.5%; n = 5) of Intervention DKA participants received pre-hospital fluid therapy. Key interview themes included clinical assessment, ambulance DKA fluid therapy, clinical handovers; decision support tool; hospital DKA management; barriers to hospital DKA care.
CONCLUSIONS: Ambulance capillary blood ketone meter use was deemed feasible, safe and acceptable. Opportunities for improved clinical decision making, support and safety-netting, as well as in-hospital DKA care, were recognised. As participant recruitment was below progression threshold, it is recommended that future-related research considers alternative trial designs.
RESULTS: gov: NCT04940897.
摘要：
目的：为了确定它是否可行，安全和可接受的救护车临床医生使用毛细血管血酮计的高风险糖尿病酮症酸中毒（DKA）识别和液体启动，告知需要全功率，多中心试验。
方法：采用阶梯式楔形控制设计，招募患有高血糖(毛细血管血糖>11.0mmol/L)或糖尿病和不适的参与者.“高风险”DKA干预参与者（毛细血管血酮≥3.0mmol/L）接受护理人员主导的液体治疗。从救护车和医院护理记录中整理了参与者的人口统计学和临床数据。采访了20名救护车和急诊科临床医生，以了解他们的高血糖症和DKA护理经验。
结果：在这项研究中，招募了388名参与者（对照：n=203；干预：n=185）。大多数表现为高血糖症，1型和2型糖尿病的发病率分别为18.5%和74.3%，分别。酮计使用促进了“高风险”DKA识别(对照:2.5%，n=5；干预：6.5%，n=12），并与改善医院预警相关。救护车临床医生似乎对医院诊断的DKA参与者有很高的怀疑指数。三分之一（33.3％；n=3）的对照组和近一半（45.5％；n=5）的干预性DKA参与者接受了院前液体治疗。主要访谈主题包括临床评估，救护车DKA液体治疗，临床交接；决策支持工具；医院DKA管理；医院DKA护理障碍。
结论：救护车毛细管血酮计的使用被认为是可行的，安全和可接受。改善临床决策的机会，支持和安全网，以及院内DKA护理，被认可。由于参与者的招募低于进展阈值，建议未来的相关研究考虑替代试验设计.
结果：gov：NCT04940897。
方法：采用阶梯式楔形控制设计，招募患有高血糖(毛细血管血糖>11.0mmol/L)或糖尿病和不适的参与者.“高风险”DKA干预参与者（毛细血管血酮≥3.0mmol/L）接受护理人员主导的液体治疗。从救护车和医院护理记录中整理了参与者的人口统计学和临床数据。采访了20名救护车和急诊科临床医生，以了解他们的高血糖症和DKA护理经验。
结果：在这项研究中，招募了388名参与者（对照：n=203；干预：n=185）。大多数表现为高血糖症，1型和2型糖尿病的发病率分别为18.5%和74.3%，分别。酮计使用促进了“高风险”DKA识别(对照:2.5%，n=5；干预：6.5%，n=12），并与改善医院预警相关。救护车临床医生似乎对医院诊断的DKA参与者有很高的怀疑指数。三分之一（33.3％；n=3）的对照组和近一半（45.5％；n=5）的干预性DKA参与者接受了院前液体治疗。主要访谈主题包括临床评估，救护车DKA液体治疗，临床交接；决策支持工具；医院DKA管理；医院DKA护理障碍。
结论：救护车毛细管血酮计的使用被认为是可行的，安全和可接受。改善临床决策的机会，支持和安全网，以及院内DKA护理，被认可。由于参与者的招募低于进展阈值，建议未来的相关研究考虑替代试验设计.
结果：gov：NCT04940897。
