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临床试验/NCT04940897
NCT04940897已完成不适用

Use of Capillary Blood Ketone Meters to Improve Ambulance Service Care of Hyperglycaemic Patients: a Feasibility Study

East of England Ambulance Service NHS Trust2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2021年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
420
试验地点
2
主要终点
Measure incidence of hyperglycaemia in study population

研究概览

简要总结

In this KARMA2 feasibility study the investigators are testing whether ambulance staff can reliably and safely identify patients at high risk of diabetic ketoacidosis using blood ketone meters and start fluid (saline) therapy before arriving at hospital. The investigators aim to include 800 patients in this stepped wedge control study and the results will help decide if a larger study is warranted.

详细描述

Diabetic ketoacidosis (DKA) is a potentially life-threatening condition which requires immediate treatment. National Health Service (NHS) hospital guidelines recommend immediate fluid (saline) therapy. Delays in diagnosis and treatment are known to be associated with health complications and death.

There is an opportunity to involve ambulance crews to improve DKA identification and treatment times; however, currently ambulance staff do not have access to ketone testing, and fluids are recommended only when it is thought a patient is critically unwell.

In this KARMA2 feasibility study the investigators are testing whether ambulance staff can reliably and safely identify patients at high risk of DKA using blood ketone meters and start fluid (saline) therapy before arriving at hospital.

During an 8-month period (4-month control followed by 4-month intervention), 120 ambulance clinicians from the East of England Ambulance Service NHS Trust will receive training to consent 400 patients with hyperglycaemia and unwell patients with diabetes to the control group receiving usual care, followed by determining the presence of ketones using capillary blood testing from a further 400 consenting patients with hyperglycaemia and unwell patients with diabetes. Subsequent patient care will depend on the ketone value obtained: high-risk DKA patients will receive fluid therapy.

Twenty ambulance and hospital clinicians will be invited to an online interview to share views of DKA care and the impact of ambulance blood ketone meters. The results will help the investigators decide if a larger study would be a good idea.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or more
  • Attended by study clinician
  • Informed or Proxy consent to participate
  • Blood glucose level greater than 11mmol/L or unwell with history of diabetes
  • If required will be transported to partner hospital

排除标准

  • Failure to meet inclusion criteria
  • Previously recruited to study

结局指标

主要结局

Measure incidence of hyperglycaemia in study population

时间窗: 18 months

Frequency count of capillary blood glucose level greater than 11mmol/L

Measure incidence of diabetic ketoacidosis (DKA) in study population

时间窗: 18 months

Frequency count of capillary blood ketone level equal to or greater than 3mmol/L

Completeness of data capture by study clinicians

时间窗: 18 months

Progression criteria requires full record completion for a minimum of 70 percent of participants

Measure incidence of adverse events

时间窗: Maximum 18 months

Progression criteria requires adverse event rate to be less than 1 percent of participants

次要结局

未报告次要终点

研究者

发起方
East of England Ambulance Service NHS Trust
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Theresa Foster

Head of Research

East of England Ambulance Service NHS Trust

研究点 (2)

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