このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

5

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Tønsberg、ノルウェー、3103
        • Vestfold Hospital Trust

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
他の: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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Cumulative Numerical Rating Scale (NRS) - during passive movement at 120 minutes after start of procedure, measured by 5 timepoints
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
血腫
時間枠:24時間
血腫 - 超音波で測定された鼠径部/注射部位の2センチメートルを超える新しい腫瘍として定義され、はいまたはいいえ
24時間
Numerical Rating Scale (NRS) - during passive movement at baseline
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:24 hours
Intravasal injection - visually + circulatory and neurological symptoms, yes or no
24 hours
Patient experience- description of pain
時間枠: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
時間枠:24 hours
Patiens experiences on waiting time to pain relief measured in a scale form 1-5
24 hours
Patient satisfaction- information
時間枠:24 hours
Patient experiences on information measured in a scale form 1-5
24 hours
Patient satisfaction- description of pain before the procedure
時間枠:24 hours
Patient experience on pre-procedure pain measured by 1-5 scale
24 hours
Patient satisfaction- description of pain after the procedure
時間枠:24 hours
Patient satisfaction- description of pain after the procedure measured by 1-5 scale
24 hours
Patient satisfaction- safety
時間枠: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
時間枠:24 hours
Patient satisfaction regarding reduction of pain after the procedure measured by a 1-5 scale
24 hours
Patient satisfaction-hearing status
時間枠:24 hours
Patient satisfaction hearing status measured by a 1-4 scale
24 hours
Self reported-registered nurse- complexity
時間枠:approximately 2 hours
Complexity of procedure measured by scale 1-5
approximately 2 hours
Self reported-registered nurse-success
時間枠:approximately 2 hours
Success of procedure measured by 1-5 scale
approximately 2 hours
Self reported-registered nurse-Recognition of anatomic structures
時間枠:approximately 2 hours
Recognition of anatomic structures at ultrasound, measured by a 1-4
approximately 2 hours
Self reported-registred nurse-spread of anesthesia
時間枠:approximately 2 hours
Spread of anesthesia, measured by a 1-4 scale
approximately 2 hours
Self reported-registered nurse- patient benefit from procedure
時間枠:approximately 2 hours
Patient benefit of procedure measured by a 1-5 scale
approximately 2 hours
Self reported-Anesthesiologist-complexity
時間枠:approximately 2 hours
Complexity of procedure measured by scale 1-5
approximately 2 hours
Self reported-Anesthesiologist-success
時間枠:approximately 2 hours
Success of procedure measured by a 1-5 scale
approximately 2 hours
Self reported-Anesthesiologist-Recognition of anatomic structures
時間枠:approximately 2 hours
Recognition of anatomic structures at ultrasound measured by a 1-4 scale
approximately 2 hours
Self reported-Anesthesiologist-spread of anesthesia
時間枠:approximately 2 hours
Spread of anesthesia, measured by a 1-4 scale
approximately 2 hours
Self reported-Anesthesiologist-Patient benefit of procedure
時間枠:approxemitely 2 hours
Patient benefit of procedure measured by a 1-5 scale
approxemitely 2 hours

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Elin Saga, nurse、The Hospital of Vestfold

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年9月19日

一次修了 (実際)

2020年1月30日

研究の完了 (実際)

2020年11月11日

試験登録日

最初に提出

2020年11月12日

QC基準を満たした最初の提出物

2020年12月2日

最初の投稿 (実際)

2020年12月9日

学習記録の更新

投稿された最後の更新 (実際)

2020年12月9日

QC基準を満たした最後の更新が送信されました

2020年12月2日

最終確認日

2020年12月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

No plan for sharing IPD

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

股関節骨折の臨床試験

Emergency nursesの臨床試験

3
購読する