Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

30. juli 2021 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Forventet)

30

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Singapore
      • Singapore, Singapore, 128038
        • Rekruttering
        • KK Women's and Children's Hospital
        • Ta kontakt med:
          • Hon Sen Tan, MD
          • Telefonnummer: +65 63947107

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Enhet: Standard clinical practice
When the desired insertion site is identified by ultrasound, the doctor demarcate the needle insertion point using marker pens.
Eksperimentell: 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.
Enhet: 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.
Andre navn:
  • PAMS

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Satisfaction survey of simulated patients and operators
Tidsramme: Immediately after performing the procedure
Satisfaction and feedback regarding the respective procedures
Immediately after performing the procedure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time taken to perform procedure
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

KK Women's and Children's Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. august 2021

Primær fullføring (Forventet)

31. august 2021

Studiet fullført (Forventet)

31. august 2021

Datoer for studieregistrering

Først innsendt

5. juli 2021

Først innsendt som oppfylte QC-kriteriene

30. juli 2021

Først lagt ut (Faktiske)

2. august 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. august 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juli 2021

Sist bekreftet

1. juli 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • PAMS 2021/2159

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Standard clinical practice

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Saudi Arabia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere