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临床试验/NCT04344418
NCT04344418Unknown不适用

Impact of Nurse-Led Focused Cardiac Ultrasound Versus Usual Care on Time to Diagnosis in Adults With Cardiorespiratory Failure: A Two-Cluster Stepped Wedge Clinical Feasibility Trial

Aga Khan University0 个研究点目标入组 732 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
732
主要终点
Time to diagnosis

研究概览

简要总结

Kenya does not have enough experts to perform heart scans in patients who are very sick and in need of urgent intervention. The purpose of this research is to find out whether training Kenyan nurses to perform basic heart scans would shorten the time it takes to know whether the heart and lungs are working normally in very sick patients, to guide treatment. Patients will be placed into one of two groups: One group will have a quick scan of the heart and lungs carried out by trained nurses to see how well these organs are working, in addition to receiving the normal care offered at the hospital. The other group will receive the normal care offered in the hospital only and will not have a scan performed by these nurses. The time it takes to make a diagnosis between the two groups will then be compared. Should the group that has heart scans by nurses be found to spend less time waiting for a diagnosis to be made, more nurses in Kenya will be trained to provide this service, to minimise delays in our emergency departments.

详细描述

Echocardiography is a useful, non-invasive diagnostic tool in time-critical emergencies. A national shortage of cardiologists and of doctors in Kenya however further compounds the problem of insufficient staff for emergency care and of any capacity building efforts. To achieve the goals of Sustainable Development Goal Number 3 (SDG-3) and realise the government's vision of universal healthcare for all, alternatives to the human resource challenge are key. Modifying the Scope of Practice of Kenyan nurses is one possible solution. Task-shifting traditionally cardiologist roles such as focused cardiac ultrasound (FoCUS) could shorten the time it takes to make a diagnosis in patients with cardiorespiratory failure of likely cardiac origin, making prolonged turnaround times in our public facilities a thing of the past. Our overarching aim is to harness the power of nurses doing FoCUS. The central hypothesis of this work is that in patients with cardiorespiratory failure, a nurse-led FoCUS-guided service would shorten time to diagnosis, supporting interventions and improving outcomes among the critically ill. Insight into potential barriers and enablers for the implementation of a nurse-performed FoCUS service in Kenya is crucial for the success of such a service redesign.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Diagnostic
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

  • Any one of:
  • Systolic blood pressure <90 millimetres of mercury (mmHg)
  • Mean arterial pressure (MAP)<65 millimetres of mercury (mmHg)
  • Shock index >1 (heart rate/systolic blood pressure)
  • Respiratory rate > 30 breaths/minute
  • Oxygen saturations <94%
  • Arterial oxygen partial pressure (paO2) <60 millimetres of mercury (mmHg)
  • Arterial carbon dioxide partial pressure (paCO2) >50 millimetres of mercury(mmHg)

排除标准

  • Pregnancy
  • Patients requiring immediate life-saving interventions eg cardiopulmonary resuscitation (CPR) or defibrillation

结局指标

主要结局

Time to diagnosis

时间窗: 24 hours

Difference in median time to diagnosis between nurse-performed FoCUS and usual care.

次要结局

  • Proportion of novice scanners able to access remote supervision for FoCUS practice.(10 months)
  • Diagnostic accuracy of nurse-performed FoCUS(10 months)
  • Proportion of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E(10 months)
  • Number of patients with cardiorespiratory failure who have a FoCUS exam performed in A&E(10 months)
  • Number of FoCUS protocol components suitable for inclusion in a local FoCUS curriculum(10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Wangari Waweru-Siika

Assistant Professor

Aga Khan University

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