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Comparison Between Pupillometry and the Numerical Rating Scale

24. august 2021 opdateret af: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Comparison Between Pupillometry and the Numerical Rating Scale for the Assessment of Pain in Communicating Adult Patients Presenting to the Emergency Room.

Given the difficulties encountered with subjective pain assessment tools, one of the ideas for reducing the occurrence of insufficient analgesia administration in the emergency department is to find a tool capable of measuring pain without requiring the patient's participation, and which could be integrated into the systematic measurement of the 4 other vitals. An interesting idea is the measurement of pupillary diameter and its reflex variations by a portable pupillometer. Indeed, the diameter of the pupil (DP) reflects the constant interactions between the sympathetic and parasympathetic systems at the level of the iris muscles. Pupillometry measures the change in pupillary diameter and allows the performance of three dynamic tests useful in the assessment of pain.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

320

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Brussel, Belgien, 1200
        • Rekruttering
        • Cliniques Universitaires Saint-Luc
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • All patients presenting to the emergency room, aged 18 years or over, able to communicate, with hemodynamic and respiratory stability, are eligible.

Exclusion Criteria:

  • - Refusal to participate in the study; refusal to sign informed consent.
  • Consent impossible to obtain (cognitive disorders, language barrier…).
  • Patient taking immediate-release opioid medication (last dose within the last 12 hours).
  • Patient taking prolonged-release opioid medication (last dose within the last 24 hours).
  • Basic treatment with a dopaminergic D2 antagonist (antipsychotic drugs).
  • Basic treatment with dopamine antagonist antiemetic medication (metoclopramide (T1/2 5-6h), domperidone (T1/2 7-9h), alizapride (T1/2 3h)) within the last 12 hours.
  • Patient taking clonidine (last dose within the last 24 hours).
  • Use of topical ocular drugs modifying pupillary parameters in the last 24 hours.
  • Bilateral eye surgery modifying the possibilities of variation in pupillary diameter bilaterally.
  • Parkinson's or Alzheimer's disease at a dysautonomic stage.
  • Admission to the emergency room for acute ocular pathology.
  • History of diabetes at a dysautonomic stage.
  • History of alcoholism at a dysautonomic stage.
  • History of glaucoma.
  • Pregnant patient with preeclampsia.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Diagnostic Test: pupillometry
Diagnostisk test: pupillometry

Step 1: The triage will be carried out by the nurse. The nurse will then perform a self-assessment of the patient's pain using a simple verbal scale.

The nurse will then record the patient's self-assessment of his pain using the numeric scale for pain.

Step 2: Immediately after this first assessment, eligible patients will be approached by the study investigator to be included in the study.

Step 3: If the patient gives informed consent, the study investigator will perform

  • The quantification of their anxiety
  • An assessment of pain by a NeuroLight videopupillometer (iDmed, Marseille, France) using two dynamic tests, the Pupillary Unrest in Ambient Light (PUAL) and the pupillary light reflex.

Step 4: One hour after the triage, a second pain assessment will be performed. Step 5: The same pupillometry measurements will be taken immediately after the nurse has assessed the pain.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The primary outcome will be the correlation between the pupillometry values and those obtained by the numerical pain rating scale with a correlation coefficient of 0.78.
Tidsramme: 1 minute
1 minute

Sekundære resultatmål

Resultatmål
Tidsramme
The evolution of the Pupillary Unrest in Ambient Light depending on the type of opioid (morphine versus weak opioid like tramadol) received by the patient.
Tidsramme: one hour
one hour
The endpoint will be the evaluation of the performance of pupillometry to predict the occurrence of Numerical Rating Scale (NRS) ≥ 4 using the ROC curve (AUC).
Tidsramme: 1 minute
1 minute
The correlation of the pupillometric parameters with the level of anxiety quantified by a numeric scale next to 1 (not anxious) to 10 (maximum level of anxiety).
Tidsramme: 1 minute
1 minute
The correlation between the initial measurement of PUAL and the analgesic response to an opioid medication.
Tidsramme: one hour
one hour
The correlation between the pain measurements obtained by the reception nurse and that obtained by the patient.
Tidsramme: 2 minutes
2 minutes
The evolution of the pupillary light reflex depending on the type of opioid (morphine versus weak opioid like tramadol) received by the patient.
Tidsramme: 1 minute
1 minute

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

4. august 2021

Primær færdiggørelse (Forventet)

1. august 2022

Studieafslutning (Forventet)

4. august 2022

Datoer for studieregistrering

Først indsendt

10. august 2021

Først indsendt, der opfyldte QC-kriterier

24. august 2021

Først opslået (Faktiske)

25. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PEWC_MAYS2021

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Smerter, Akut

Kliniske forsøg med pupillometry

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