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How to Develop a Training Program for Nurses in Ultrasound Guided Femoral Nerve Block

2020年12月2日 更新者:Espen Lindholm、Sykehuset i Vestfold HF

How to Develop a Training Program for Nurses in Ultrasound Guided Femoral - a Methodology Study

In this study the intervention consists of a one-day-training program for nurses and three supervised ultrasound guided femoral nerve block (UGFNB) per registered nurse.

The training consists of an instruction movie, one-day on-site-simulation and practical examination. The nurses are watching an instruction video and review current local guidelines for UGFNB in advance. The one-day training is situated in a simulation center and consists of theoretical and practical training divided into; infection prevention, anatomy, use of ultrasound and prevention and treatment of complications. A ultrasound model (Gen II Femoral Vascular Access and Regional Anesthesia Ultrasound Training Model) and a living human model is used to examine the femoral nerve and the neighboring structures using ultrasound. At the end of the one-day course, the nurses attends a practical examination with the researchers and anesthesiologists observing, to assure that they could perform the UGFNB procedure correctly. To pass the exam and be able to move on to the supervised blocks in real patients, there has to be a consensus between the researchers and anesthesiologist that they had sufficient knowledge and practical skills. 1) Sterile procedure 2) Management of the ultrasound machine and oral description of the anatomic surroundings in the groin area 3) Preparation of the local anesthetics and performance of an UGFNB. They also have to do an oral presentation in how they would perform a cardiopulmonary resuscitation procedure and how to manage complications / toxic reactions. Approved exam required at least seven points. This study will explore if a one-day course as described above is adequate, sufficient and maintains the safety framework of performing UGFNB in nurses

研究概览

详细说明

Acute pain is a common reason for patients admitted to Emergency Departments (ED) . Globally over 1 million hip fractures occur yearly , a trauma that is close related with acute distinct pain in the proximal part of the affected extremity. Experiencing severe pain is associated with increased length of stay, higher risk of delirium, movement restriction, difficulties with mobilization and reduced health related quality of life. There is considerable research regarding patients' satisfaction with their ED experiences. These studies indicate that patient dissatisfaction with the stay at ED has been an international challenge over several years . Disapproval such as; pain management , but also limited information on potential latency before further treatment and poor explanation about the causes and treatment of the condition is prominent.

Pain control can be difficult , and often requires advanced nursing and physician care due to co-morbidity . Inadequate analgesia appear to be risk factors for delirium in frail older adults, and research indicates that total avoiding opioids or using very low or high doses of opioids may increase the risk of delirium. Therefore, optimizing acute pain management is important. Ultrasound Guided Femoral Nerve block (UGFNB) performed in hip fracture patients is a valuable alternative to systemic analgesic, as it provides analgesia to the fractured area, thereby facilitating reduction in opioid administration. Traditionally, an UGFNB is performed by an anesthesiologist. Recently, several examples of task shifting from physicians to nurses are described with no significant difference in successful treatment results with equal patients satisfaction and safety as physician performed procedures. Task shifting approach is endorsed by the World Health Organization (WHO) in order to make more efficient use of the available human resource of health. A recent report from the European Union (EU) states that implementation of task shifting has been rarely evaluated and limited documented. Therefore, we need studies to examine the methodology in how we can train nurses in the ED to take more responsibility for assessing and treating patients.

In the study we aime to;

  1. describe a methodology for a training course for nurse led UGFNB.
  2. evaluate if the training process resulted in a safe and successful UGFNB.

Data which will be collected are

  1. ASA classification (ASA Physical Status Classification System )
  2. Length of stay
  3. Morbidity

    • Hospital acquired pneumonia
    • Acute myocardial infarction (AMI)
    • Acute renal failure
    • Respiratory failure
  4. Complication rate, number of;

    • intravasal injection - visually + circulatory and neurological symptoms
    • hematoma - defined as a new tumor > 2 cm in the groin / injection site measured by ultrasound
    • Neurologic systemic outcomes / symptoms / paresthesia that have occurred after admission and which persist until discharge.
    • Allergic reaction
  5. Number of total morphine equivalents, mg (iv/po) administered prehospital and during Emergency Department stay
  6. Patients physical characteristic (physical examination; gender, age, height, weight, , blood pressure, heart rate, SpO2 (oxygen saturation) and use of oxygen will be noted together with current disease

A short, but personal interview with the patients having received an UGFNB by a study nurse can describe both the service received and the patient's experience with it. The interviews will be performed after the patient has been relieved of pain. The PhD (Philosophiae Doctor)-candidate, not the study nurse having performed the nerve block, will conduct the interviews. The patients will be asked whether the nerve block relieved them of pain, how they experienced the procedure and the fact that it was performed by a nurse had any relevance. Also, the PhD-candidate will interview the patient at a later point during the hospital stay for a second time to compare the answers

The study nurses and the anesthesiologists that has supervised the nurses will be presented with a questionnaire after each UGFNB conducted. The PhD-candidate will hand out the questionnaire immediately after the FNB is conducted by a study nurse. The items in the questionnaire include feasibility and success of the procedure and are identical for nurses and anesthesiologists.

Finally, each study nurse will do three UGFNB with supervision by an anesthesiologist before we start inclusion in a later randomized controlled trial. Five study nurses will be included and fifteen patients.

The inclusion criteria for patients will be:

  • Patients arriving at the ED diagnosed with a hip fracture (radiological confirmed)
  • ASA- classification 1-4
  • Written and verbal informed consent by patient

Exclusion criteria for patients will be:

  • Patients with; dementia, without ability to give informed consent and other cognitively challenges needed to participate in this study (at the discretion of the study nurse)
  • Known allergies to local anesthetic (Ropivacaine) used in UGFNB
  • Use of anticoagulants or platelet inhibitors. Acetylsalicylic acid and dipyridamole is allowed. If a recent (last 2 hours) INR( international normalized ratio) is below <1.5 the patient can be included.
  • Pregnant
  • Age <18 years
  • Severe head injury which leads to significant loss of consciousness (GCS <12)
  • >10 mg or more morphine administrated pre-hospital
  • Skin lesions/infection at presumed block site
  • Patients admitted with other suspected or verified fractures, except small fractures in hands and foots.

Verbal and written informed consent The study nurses will inform the patients by oral and written information and inclusion and intervention of the patient will start after written consent.

研究类型

介入性

注册 (实际的)

5

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Tønsberg、挪威、3103
        • Vestfold Hospital trust

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Registered nurses or registered nurses with continuing education in acute nursing or geriatrics
  • The nurses need to be aware that it will increase the workload in beginning of the project.
  • Registered nurse has to be senior staff experienced i.e. worked in the ED
  • Motivated to take on a new task in the ED
  • Certificated in advanced CPR
  • Familiar with routines in the ED and the relevant patient group
  • They must be willing to be a part of this project for approximately 12 months.
  • Working at least 75%.

Exclusion Criteria:

  • Refuse to participate

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Emergency nurses
Emergency nurses who are trained in an one-day course
Emergency nurses who are trained for one-day in ultrasound-guided femoral nerve block

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Cumulative Numerical Rating Scale (NRS) - during passive movement at 120 minutes after start of procedure, measured by 5 timepoints
大体时间:120 minutes
Cumulative Numerical Rating Scale (NRS) - during passive movement (30 degree flexion in the fractured hip) in patients with hip fracture during stay in the ED at 120 minutes after admission, measured by five time Points; At the end of procedure, 30 min.-, 60 min.-, 90 min.- and 120 min after start of procedure. NRS score: 0 is no pain and 10 is the worst pain.
120 minutes

次要结果测量

结果测量
措施说明
大体时间
血肿
大体时间:24小时
血肿 - 定义为通过超声测量的腹股沟/注射部位 > 2 厘米的新肿瘤,是或否
24小时
Numerical Rating Scale (NRS) - during passive movement at baseline
大体时间:At baseline (timepoint 0)
Numerical Rating Scale (NRS) - during passive movement (30 degree flexion in the fractured hip) in patients with hip fracture during stay in the ED at baseline (inclution of patient) NRS score: 0 is no pain and 10 is the worst pain.
At baseline (timepoint 0)
Numerical Rating Scale (NRS) - during passive movement after 30 minutes
大体时间:After 30 minutes from baseline
Numerical Rating Scale (NRS) - during passive movement (30 degree flexion in the fractured hip) in patients with hip fracture during stay in the ED after 30 minutes from baseline NRS score: 0 is no pain and 10 is the worst pain.
After 30 minutes from baseline
Numerical Rating Scale (NRS) - during passive movement after 60 minutes
大体时间:After 60 minutes from baseline
Numerical Rating Scale (NRS) - during passive movement (30 degree flexion in the fractured hip) in patients with hip fracture during stay in the ED after 60 minutes from baseline NRS score: 0 is no pain and 10 is the worst pain.
After 60 minutes from baseline
Numerical Rating Scale (NRS) - during passive movement after 90 minutes
大体时间:After 90 minutes from baseline
Numerical Rating Scale (NRS) - during passive movement (30 degree flexion in the fractured hip) in patients with hip fracture during stay in the ED after 90 minutes from baseline NRS score: 0 is no pain and 10 is the worst pain.
After 90 minutes from baseline
Numerical Rating Scale (NRS) - during passive movement after 120 minutes
大体时间:After 120 minutes from baseline
Numerical Rating Scale (NRS) - during passive movement (30 degree flexion in the fractured hip) in patients with hip fracture during stay in the ED after 120 minutes from baseline NRS score: 0 is no pain and 10 is the worst pain.
After 120 minutes from baseline
Intravasal injection
大体时间:24 hours
Intravasal injection - visually + circulatory and neurological symptoms, yes or no
24 hours
Patient experience- description of pain
大体时间:24 hours
Patient experience of pain- During rest and motion measured by a 1-5 scale
24 hours
Patient satisfaction- waiting time to pain relief
大体时间:24 hours
Patiens experiences on waiting time to pain relief measured in a scale form 1-5
24 hours
Patient satisfaction- information
大体时间:24 hours
Patient experiences on information measured in a scale form 1-5
24 hours
Patient satisfaction- description of pain before the procedure
大体时间:24 hours
Patient experience on pre-procedure pain measured by 1-5 scale
24 hours
Patient satisfaction- description of pain after the procedure
大体时间:24 hours
Patient satisfaction- description of pain after the procedure measured by 1-5 scale
24 hours
Patient satisfaction- safety
大体时间:24 hours
Patient satisfaction- description of patient reported feeling of safety during nurse led procedure measured by a 1-5 scale
24 hours
Patient satisfaction-effect of procedure
大体时间:24 hours
Patient satisfaction regarding reduction of pain after the procedure measured by a 1-5 scale
24 hours
Patient satisfaction-hearing status
大体时间:24 hours
Patient satisfaction hearing status measured by a 1-4 scale
24 hours
Self reported-registered nurse- complexity
大体时间:approximately 2 hours
Complexity of procedure measured by scale 1-5
approximately 2 hours
Self reported-registered nurse-success
大体时间:approximately 2 hours
Success of procedure measured by 1-5 scale
approximately 2 hours
Self reported-registered nurse-Recognition of anatomic structures
大体时间:approximately 2 hours
Recognition of anatomic structures at ultrasound, measured by a 1-4
approximately 2 hours
Self reported-registred nurse-spread of anesthesia
大体时间:approximately 2 hours
Spread of anesthesia, measured by a 1-4 scale
approximately 2 hours
Self reported-registered nurse- patient benefit from procedure
大体时间:approximately 2 hours
Patient benefit of procedure measured by a 1-5 scale
approximately 2 hours
Self reported-Anesthesiologist-complexity
大体时间:approximately 2 hours
Complexity of procedure measured by scale 1-5
approximately 2 hours
Self reported-Anesthesiologist-success
大体时间:approximately 2 hours
Success of procedure measured by a 1-5 scale
approximately 2 hours
Self reported-Anesthesiologist-Recognition of anatomic structures
大体时间:approximately 2 hours
Recognition of anatomic structures at ultrasound measured by a 1-4 scale
approximately 2 hours
Self reported-Anesthesiologist-spread of anesthesia
大体时间:approximately 2 hours
Spread of anesthesia, measured by a 1-4 scale
approximately 2 hours
Self reported-Anesthesiologist-Patient benefit of procedure
大体时间:approxemitely 2 hours
Patient benefit of procedure measured by a 1-5 scale
approxemitely 2 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Elin Saga, nurse、The Hospital of Vestfold

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年9月19日

初级完成 (实际的)

2020年1月30日

研究完成 (实际的)

2020年11月11日

研究注册日期

首次提交

2020年11月12日

首先提交符合 QC 标准的

2020年12月2日

首次发布 (实际的)

2020年12月9日

研究记录更新

最后更新发布 (实际的)

2020年12月9日

上次提交的符合 QC 标准的更新

2020年12月2日

最后验证

2020年12月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

No plan for sharing IPD

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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