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

2 dicembre 2020 aggiornato da: 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

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

5

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Tønsberg, Norvegia, 3103
        • Vestfold Hospital Trust

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cumulative Numerical Rating Scale (NRS) - during passive movement at 120 minutes after start of procedure, measured by 5 timepoints
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Ematoma
Lasso di tempo: 24 ore
Ematoma - definito come un nuovo tumore > 2 centimetri nell'inguine / sito di iniezione misurato mediante ultrasuoni, sì o no
24 ore
Numerical Rating Scale (NRS) - during passive movement at baseline
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 24 hours
Intravasal injection - visually + circulatory and neurological symptoms, yes or no
24 hours
Patient experience- description of pain
Lasso di tempo: 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
Lasso di tempo: 24 hours
Patiens experiences on waiting time to pain relief measured in a scale form 1-5
24 hours
Patient satisfaction- information
Lasso di tempo: 24 hours
Patient experiences on information measured in a scale form 1-5
24 hours
Patient satisfaction- description of pain before the procedure
Lasso di tempo: 24 hours
Patient experience on pre-procedure pain measured by 1-5 scale
24 hours
Patient satisfaction- description of pain after the procedure
Lasso di tempo: 24 hours
Patient satisfaction- description of pain after the procedure measured by 1-5 scale
24 hours
Patient satisfaction- safety
Lasso di tempo: 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
Lasso di tempo: 24 hours
Patient satisfaction regarding reduction of pain after the procedure measured by a 1-5 scale
24 hours
Patient satisfaction-hearing status
Lasso di tempo: 24 hours
Patient satisfaction hearing status measured by a 1-4 scale
24 hours
Self reported-registered nurse- complexity
Lasso di tempo: approximately 2 hours
Complexity of procedure measured by scale 1-5
approximately 2 hours
Self reported-registered nurse-success
Lasso di tempo: approximately 2 hours
Success of procedure measured by 1-5 scale
approximately 2 hours
Self reported-registered nurse-Recognition of anatomic structures
Lasso di tempo: approximately 2 hours
Recognition of anatomic structures at ultrasound, measured by a 1-4
approximately 2 hours
Self reported-registred nurse-spread of anesthesia
Lasso di tempo: approximately 2 hours
Spread of anesthesia, measured by a 1-4 scale
approximately 2 hours
Self reported-registered nurse- patient benefit from procedure
Lasso di tempo: approximately 2 hours
Patient benefit of procedure measured by a 1-5 scale
approximately 2 hours
Self reported-Anesthesiologist-complexity
Lasso di tempo: approximately 2 hours
Complexity of procedure measured by scale 1-5
approximately 2 hours
Self reported-Anesthesiologist-success
Lasso di tempo: approximately 2 hours
Success of procedure measured by a 1-5 scale
approximately 2 hours
Self reported-Anesthesiologist-Recognition of anatomic structures
Lasso di tempo: approximately 2 hours
Recognition of anatomic structures at ultrasound measured by a 1-4 scale
approximately 2 hours
Self reported-Anesthesiologist-spread of anesthesia
Lasso di tempo: approximately 2 hours
Spread of anesthesia, measured by a 1-4 scale
approximately 2 hours
Self reported-Anesthesiologist-Patient benefit of procedure
Lasso di tempo: approxemitely 2 hours
Patient benefit of procedure measured by a 1-5 scale
approxemitely 2 hours

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Elin Saga, nurse, The Hospital of Vestfold

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 settembre 2019

Completamento primario (Effettivo)

30 gennaio 2020

Completamento dello studio (Effettivo)

11 novembre 2020

Date di iscrizione allo studio

Primo inviato

12 novembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

2 dicembre 2020

Primo Inserito (Effettivo)

9 dicembre 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 dicembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 dicembre 2020

Ultimo verificato

1 dicembre 2020

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

No plan for sharing IPD

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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