Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Position and Angle Marking System (PAMS) for Ultrasound-guided Neuraxial Procedures

30 juli 2021 bijgewerkt door: Paul Tan Hon Sen, KK Women's and Children's Hospital

Epidural anaesthesia involves the administration of numbing medication (local anaesthetics) close to the spinal canal, and is regarded as the best method for providing pain relief during labour and childbirth. The use of ultrasound to guide epidural insertion and placement has been shown to improve pain relief and reduce the risk of complications.

However, after identifying the desired needle insertion site via ultrasound, current practice involves demarcating the insertion site using marker pens, which is time-consuming, inaccurate, and may be inadvertently removed by skin sterilisation. Furthermore, the desired needle angulation determined by ultrasound cannot be accurately measured and maintained during the epidural procedure. Both issues limit the benefits of using ultrasound to guide the epidural procedure.

To address these issues, the investigators developed a Position and Angular Marking System (PAMS) that attaches on to the ultrasound probe. When the desired insertion site is identified by ultrasound, the doctor gently presses PAMS into the patient's back to create skin indentations demarcating the needle insertion point. These indentations are not affected by skin sterilisation, and may improve accuracy and reduce the time taken to perform the epidural procedure. Next, the angle between the ultrasound probe and the patient's back can be measured using PAMS, and this angle can be maintained using a needle guide during the epidural procedure.

The purpose of this randomised study is to evaluate the usability of PAMS and to identify areas for further improvement.

This study will involve up to 10 healthy simulated patients, and up to 30 volunteer ultrasound operators. After undergoing a standardised training session with a mannequin, the ultrasound operators will be randomly assigned to perform skin marking on the simulated patients as though they are performing an ultrasound-guided epidural anaesthesia procedure (no needle puncture will be made) using either PAMS, or standard clinical practice with marker pens. After completing the procedure, the ultrasound operators will cross over and perform the procedure again using either PAMS or standard clinical practice with marker pens.

Both the ultrasound operators and simulated patients will be asked to complete satisfaction and usability surveys regarding their experience with the procedures.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

The volunteer ultrasound operators are women's anaesthesiologists trained in the use of ultrasound-guided neuraxial procedures.

Simulated patients are healthy volunteers from other departments, without spine abnormalities.

The ultrasound operators will be asked to complete a questionnaire regarding your prior experience with neuraxial ultrasonography and undergo structured training on the use of PAMS using a mannequin. Next, they will be asked to perform the following two procedures (the order at which they will perform the procedures will be randomised):

  1. Ultrasound scan using PAMS

    • After attaching PAMS to the ultrasound probe, they will perform a lumbar ultrasound scan on a simulated patient to identify the desired needle insertion site and gently press PAMS into the simulated patient's back to create skin indentations demarcating the desired needle insertion site.
    • Next, adjust the angulation of the ultrasound probe to optimise the image of the simulated patient's lumbar spine, and read the angle between the ultrasound probe and patient's back off a graduated scale.
    • Remove the ultrasound probe, and position the needle-insertion guide corresponding to the skin indentations. Needle angulation can be simulated by mounting a blunt needle on to the insertion guide.
    • Finally, they will be asked to complete a usability questionnaire.

  2. Ultrasound scan without PAMS (standard clinical practice)

    • Perform a lumbar ultrasound scan to identify the desired needle insertion site, followed by demarcation using skin markers.
    • Next, adjust the angulation of the ultrasound probe to optimise the image of the simulated patient's lumbar spine.
    • Remove the ultrasound probe and simulate needle insertion by touching the tip of a blunt needle to the patient's back, at the desired angle.
    • Finally, they will then be asked to complete a usability questionnaire.

Both procedures are non-invasive (i.e. no skin punctures will be made). No follow up is required for this study.

No new research medications are involved in this study.

Additionally, video recordings may be made of the procedures. Any video or ultrasound images obtained during the course of this study will be stored and analysed only for the purposes of this study for a period not exceeding 7 years, and will be destroyed after completion of the study. Technical data such as the scanning duration and success rate will also be documented.

Studietype

Ingrijpend

Inschrijving (Verwacht)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Singapore
      • Singapore, Singapore, 128038
        • Werving
        • KK Women's and Children's Hospital
        • Contact:
          • Hon Sen Tan, MD
          • Telefoonnummer: +65 63947107

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Ultrasound operators

Inclusion Criteria:

  • Anaesthesiologists
  • Trained in the use of ultrasound-guided neuraxial procedures

Exclusion Criteria:

  • No experience with ultrasound-guided neuraxial procedures

Simulated patients

Inclusion Criteria:

  • Healthy, no significant medical comorbidity (American Society of Anesthesiologists Physical Status I or II)
  • No spinal abnormalities, or previous spinal surgery

Exclusion Criteria:

  • Significant spinal abnormality
  • Previous spinal surgery

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Standard clinical practice
  • Lumbar ultrasound scan will be performed to identify the desired needle insertion site, followed by demarcation using skin markers.
  • The angulation of the ultrasound probe will be adjusted to optimise the image of the simulated patient's lumbar spine.
  • The ultrasound probe will be removed and needle insertion simulated by touching the tip of a blunt needle to the patient's back, at the desired angle.
  • A usability questionnaire regarding the procedure will be completed.
Apparaat: Standard clinical practice
When the desired insertion site is identified by ultrasound, the doctor demarcate the needle insertion point using marker pens.
Experimenteel: Position and Angle Marking System (PAMS)
  • PAMS will be attached to the ultrasound probe.
  • Lumbar ultrasound scan will be performed to identify the desired needle insertion site, followed by demarcation by gentle pressing PAMS into the simulated patient's back to create skin indentations.
  • The angulation of the ultrasound probe will be adjusted to optimise the image of the simulated patient's lumbar spine, and the angle read off a graduated scale.
  • The ultrasound probe will be removed and needle insertion simulated by touching the tip of a blunt needle to the patient's back, at the desired angle.
  • A usability questionnaire regarding the procedure will be completed.
Apparaat: Position and Angle Marking System
Position and Angular Marking System (PAMS) attaches on to the ultrasound probe. When the desired insertion site is identified by ultrasound, the doctor gently presses PAMS into the patient's back to create skin indentations demarcating the needle insertion point. These indentations are not affected by skin sterilisation, and may improve accuracy and reduce the time taken to perform the epidural procedure. Next, the angle between the ultrasound probe and the patient's back can be measured using PAMS, and this angle can be maintained using a needle guide during the epidural procedure.
Andere namen:
  • PAMS

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Satisfaction survey of simulated patients and operators
Tijdsspanne: Immediately after performing the procedure
Satisfaction and feedback regarding the respective procedures
Immediately after performing the procedure

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time taken to perform procedure
Tijdsspanne: Immediately after performing the procedure
Comparison of time taken to perform the interventional procedure (PAMS), versus standard clinical practice (control)
Immediately after performing the procedure

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

KK Women's and Children's Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 augustus 2021

Primaire voltooiing (Verwacht)

31 augustus 2021

Studie voltooiing (Verwacht)

31 augustus 2021

Studieregistratiedata

Eerst ingediend

5 juli 2021

Eerst ingediend dat voldeed aan de QC-criteria

30 juli 2021

Eerst geplaatst (Werkelijk)

2 augustus 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 augustus 2021

Laatste update ingediend die voldeed aan QC-criteria

30 juli 2021

Laatst geverifieerd

1 juli 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • PAMS 2021/2159

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Ultrasound-guided Neuraxial Procedures

Klinische onderzoeken op Standard clinical practice

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Bahrain

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren